Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

NCT06958328 | Recruiting Phase 3

• 3 other identifiers: NRG-GI011NCI-2025-01624U10CA180868
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 279

Brief Summary

This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.

Conditions

Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS will be estimated by the Kaplan-Meier method (Kaplan 1958). The 3-year OS estimates between the two arms will be compared using a Z-test. A logistic regression model will be used to analyze the effects of factors, in addition to treatment, including, but not limited to the stratification factor, which may be associated with 3-year OS. The primary hypothesis of improved 3-year OS will be tested with a 1-sided significance level of 0.023 (level based on not having stopped at either of the 2 planned interim analyses).

  From randomization to the date of death or last follow-up, assessed up to 3 years

Secondary Outcomes (5)

• Local progression (LP)

  From randomization to date of failure, date of death (competing event), or last known follow-up date, assessed up to 5 years

• Progression-free survival (PFS)

  From the date of randomization to the date of first PFS failure or last follow-up for patients without a reported PFS event, assessed up to 5 years

• Chemotherapy-free interval (CFI)

  From the date of last dose of initial chemotherapy to the date of first dose of second line chemotherapy for progression, assessed up to 5 years

• Long-term radiation-related ≥ grade 3 adverse events

  Up to 1 year after randomization

• Incidence of ≥ grade 3 adverse events

  Up to 90 days after randomization

Other Outcomes (3)

• Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score at 6 months

  At 6 months

• FACT-Hep score nadir

  From baseline to 24 months from randomization

• FACT-Hep total score over time

  From baseline to 24 months from randomization

Study Arms (2)

Arm I (Options 1, 2, or 3)

ACTIVE COMPARATOR

See Detailed Description.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Capecitabine; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Irinotecan Hydrochloride; Drug: Irinotecan Sucrosofate; Drug: Leucovorin Calcium; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Other: Observation Activity; Drug: Oxaliplatin; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Radiation Therapy

Arm II (dose-escalated RT)

EXPERIMENTAL

Patients undergo dose-escalated RT daily, every other day, or twice weekly for 5 fractions or daily for 25 fractions (with or without concurrent fluorouracil or capecitabine for 25 fractions only). The 5-fraction regimen is preferred when feasible. After completing dose-escalated RT, patients who received less than 6 months of chemotherapy at study entry are encouraged to receive the remaining chemotherapy to total 6 months of chemotherapy. Patients may continue chemotherapy treatment beyond 6 months at physician's discretion. Additionally, patients undergo blood sample collection, CT, MRI and tumor tissue biopsy throughout the study. Patients may optionally undergo PET/CT prior to treatment.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Capecitabine; Procedure: Computed Tomography; Radiation: Dose-escalated Radiation Therapy; Drug: Fluorouracil; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

Interventions

Dose-escalated Radiation Therapy RADIATION

Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning

Also known as: Dose-escalated RT

Arm II (dose-escalated RT)

Irinotecan Hydrochloride DRUG

Given irinotecan hydrochloride

Also known as: Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, CPT11, Irinomedac, Irinotecan Hydrochloride Trihydrate, Irinotecan Monohydrochloride Trihydrate, U 101440E, U-101440E, U101440E

Arm I (Options 1, 2, or 3)

Irinotecan Sucrosofate DRUG

Given liposomal irinotecan

Also known as: inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation, Irinotecan Liposome, Irinotecan Sucrosofate Liposome, Irinotecan Sucrosofate-containing Pegylated Liposomal Formulation, MM 398, MM-398, MM398, nal-IRI, Nanoliposomal Irinotecan, Nanoliposomal Irinotecan as Sucrosofate, Nanoparticle Liposome Formulation of Irinotecan, Onivyde, PEP 02, PEP-02, PEP02

Arm I (Options 1, 2, or 3)

Nab-paclitaxel DRUG

Given nab-paclitaxel

Also known as: ABI 007, ABI-007, ABI007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Naveruclif, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Paclitaxel Nanoparticle Albumin-bound, Paclitaxel Protein-Bound, Protein-bound Paclitaxel

Arm I (Options 1, 2, or 3)

Observation Activity OTHER

Undergo observation

Also known as: Observation

Arm I (Options 1, 2, or 3)

Gemcitabine DRUG

Given gemcitabine

Also known as: dFdC, dFdCyd, Difluorodeoxycytidine

Arm I (Options 1, 2, or 3)

Leucovorin Calcium DRUG

Given leucovorin calcium

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Arm I (Options 1, 2, or 3)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Biopsy Procedure PROCEDURE

Undergo tumor tissue biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Capecitabine DRUG

Given capecitabine

Also known as: Ro 09-1978/000, Xeloda

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Fluorouracil DRUG

Given fluorouracil

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Oxaliplatin DRUG

Given oxaliplatin

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, Elplat, JM 83, JM-83, JM83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, RP54780, SR 96669, SR-96669, SR96669

Arm I (Options 1, 2, or 3)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Options 1, 2, or 3); Arm II (dose-escalated RT)

Radiation Therapy RADIATION

Undergo standard radiation therapy

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm I (Options 1, 2, or 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for toxicity reasons, but not for disease progression. "Active chemotherapy" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle
• BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
• Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma
• Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \[NCCN\] guidelines and institutional tumor board review)
• Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to enrollment
• Age ≥ 18 years
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
• Required initial laboratory values:
• All laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
• BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of post-chemotherapy eligibility criteria
• If baseline CA19-9 \> 37 U/mL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as done within specified timeframe \[up to 30 days post chemotherapy initiation\])
• If baseline CA19-9 U/mL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value
• Prior radiation treatment
• Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Sponsors & Collaborators

• NRG Oncology: lead

Study Sites (279)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, 85297, United States

RECRUITING

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, 85381, United States

RECRUITING

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, 85027, United States

RECRUITING

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, 85258, United States

RECRUITING

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, 85374, United States

RECRUITING

Arizona Center for Cancer Care

Tempe, Arizona, 85284, United States

RECRUITING

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

RECRUITING

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, 93301, United States

RECRUITING

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

RECRUITING

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

RECRUITING

Palo Alto Medical Foundation-Fremont

Fremont, California, 94538, United States

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Memorial Medical Center

Modesto, California, 95355, United States

RECRUITING

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040, United States

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

RECRUITING

Sutter Roseville Medical Center

Roseville, California, 95661, United States

RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

RECRUITING

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

RECRUITING

Mills Health Center

San Mateo, California, 94401, United States

RECRUITING

Ridley-Tree Cancer Center

Santa Barbara, California, 93105, United States

RECRUITING

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

RECRUITING

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

RECRUITING

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

RECRUITING

BASS Medical Group - Lennon

Walnut Creek, California, 94598, United States

ACTIVE NOT RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

ACTIVE NOT RECRUITING

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907, United States

RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

RECRUITING

AdventHealth Porter

Denver, Colorado, 80210, United States

RECRUITING

AdventHealth Littleton

Littleton, Colorado, 80122, United States

RECRUITING

AdventHealth Parker

Parker, Colorado, 80138, United States

RECRUITING

Danbury Hospital

Danbury, Connecticut, 06810, United States

RECRUITING

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

NOT YET RECRUITING

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

NOT YET RECRUITING

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, 06033, United States

NOT YET RECRUITING

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

NOT YET RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

NOT YET RECRUITING

Smilow Cancer Hospital-Hamden Care Center

Hamden, Connecticut, 06518, United States

RECRUITING

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

NOT YET RECRUITING

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

NOT YET RECRUITING

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

RECRUITING

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

NOT YET RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

NOT YET RECRUITING

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

NOT YET RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

NOT YET RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont Hospital

Atlanta, Georgia, 30309, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

RECRUITING

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States

RECRUITING

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

RECRUITING

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

RECRUITING

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

RECRUITING

Kuakini Medical Center

Honolulu, Hawaii, 96817, United States

RECRUITING

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States

RECRUITING

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

RECRUITING

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

RECRUITING

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

RECRUITING

Queen's Cancer Center - Pearlridge

‘Aiea, Hawaii, 96701, United States

RECRUITING

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, 96701, United States

RECRUITING

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706, United States

RECRUITING

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Carle at The Riverfront

Danville, Illinois, 61832, United States

RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

RECRUITING

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

RECRUITING

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States

RECRUITING

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States

RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

RECRUITING

Northwestern Medicine Oak Brook

Oak Brook, Illinois, 60523, United States

RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Clinic

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

RECRUITING

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

RECRUITING

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

RECRUITING

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

Salina Regional Health Center

Salina, Kansas, 67401, United States

RECRUITING

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530, United States

RECRUITING

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102, United States

RECRUITING

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States

RECRUITING

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States

RECRUITING

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, 04106, United States

RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

William E Kahlert Regional Cancer Center/Sinai Hospital

Westminster, Maryland, 21157, United States

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

RECRUITING

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States

RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States

RECRUITING

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116, United States

RECRUITING

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States

RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States

RECRUITING

Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

RECRUITING

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Allegiance Health

Jackson, Michigan, 49201, United States

RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

RECRUITING

Beacon Kalamazoo

Kalamazoo, Michigan, 49048, United States

RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

RECRUITING

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States

RECRUITING

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341, United States

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

RECRUITING

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764, United States

RECRUITING

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

RECRUITING

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, 48192, United States

RECRUITING

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705, United States

RECRUITING

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

RECRUITING

Jefferson Cherry Hill Hospital

Cherry Hill, New Jersey, 08002, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

New York-Presbyterian/Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

East White Plains, New York, 10604, United States

RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

RECRUITING

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

RECRUITING

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Miami Valley Hospital

Dayton, Ohio, 45409, United States

RECRUITING

Premier Blood and Cancer Center

Dayton, Ohio, 45409, United States

RECRUITING

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

RECRUITING

Dublin Methodist Hospital

Dublin, Ohio, 43016, United States

RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

RECRUITING

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States

RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

RECRUITING

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

RECRUITING

Upper Valley Medical Center

Troy, Ohio, 45373, United States

RECRUITING

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Jefferson Hospital

Jefferson Hills, Pennsylvania, 15025, United States

RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

RECRUITING

Forbes Hospital

Monroeville, Pennsylvania, 15146, United States

RECRUITING

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Reading Hospital

West Reading, Pennsylvania, 19611, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

RECRUITING

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

RECRUITING

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

RECRUITING

Houston Methodist San Jacinto Hospital

Baytown, Texas, 77521, United States

RECRUITING

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

RECRUITING

Houston Methodist Cypress Hospital

Cypress, Texas, 77429, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Ben Taub General Hospital

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Methodist Willowbrook Hospital

Houston, Texas, 77070, United States

RECRUITING

MD Anderson West Houston

Houston, Texas, 77079, United States

RECRUITING

Houston Methodist West Hospital

Houston, Texas, 77094, United States

RECRUITING

MD Anderson League City

League City, Texas, 77573, United States

RECRUITING

Houston Methodist Saint John Hospital

Nassau Bay, Texas, 77058, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

RECRUITING

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479, United States

RECRUITING

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, 77385, United States

RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

RECRUITING

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Inova Fair Oaks Hospital

Fairfax, Virginia, 22033, United States

RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Inova Loudoun Hospital

Leesburg, Virginia, 20176, United States

RECRUITING

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, 23116, United States

RECRUITING

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114, United States

RECRUITING

Bon Secours Saint Mary's Hospital

Richmond, Virginia, 23226, United States

RECRUITING

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, 23230, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States

RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154, United States

RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States

RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy; Specimen Handling; Capecitabine; Fluorouracil; dehydroftorafur; Gemcitabine; Irinotecan; irinotecan sucrosofate; Leucovorin; Magnetic Resonance Spectroscopy; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; Observation; Oxaliplatin; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Spectrum Analysis; Chemistry Techniques, Analytical; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Methods; Coordination Complexes; Therapeutics; Physical Phenomena

Study Officials

• Nina N Sanford

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 6, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): October 21, 2030
• Study Completion (Estimated): October 21, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (279)