NCT07283939

Brief Summary

This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

271 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026May 2030

First Submitted

Initial submission to the registry

December 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 13, 2026

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2030

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

December 1, 2025

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of unplanned chemotherapy delays

    Will employ a generalized linear mixed effects model with logit link function, with a random patient effect to account for clustering of cycles within patients. Will test if additional random effects are needed (e.g., provider or clinic level). Statistical significance will be assessed at the 5% level. Delays will be assessed over cycles 2 through 7, and a delay will be defined as an interval of \> 18 days since day 1 of the previous cycle. An unplanned delay will be defined as any delay that was not prospectively planned by day 3 of the previous cycle.

    From cycle 2 to 7 (Undelayed cycle length= 14 days)

Secondary Outcomes (3)

  • Time toxicity

    From registration to 120 days after registration.

  • Moderate-to-severe neutropenia

    From the start of cycle 2 to 30 days after start of cycle 7 (undelayed cycle length= 14 days)

  • Chemotherapy relative dose intensity

    Time Frame: From the start of cycle 1 to day 14 of cycle 6 (undelayed cycle length= 14 days).

Study Arms (2)

Arm B- PAGODA Algorithm

EXPERIMENTAL

Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.

Other: PAGODA algorithmDrug: OxaliplatinDrug: Folinic AcidDrug: Fluorouracil

Arm A- Physician Discretion

ACTIVE COMPARATOR

Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study.

Drug: OxaliplatinDrug: Folinic AcidDrug: Fluorouracil

Interventions

use PAGODA algorithm to determine chemotherapy delays and dose modifications

Arm B- PAGODA Algorithm

Given IV

Arm A- Physician DiscretionArm B- PAGODA Algorithm

Given IV

Also known as: Leucovorin
Arm A- Physician DiscretionArm B- PAGODA Algorithm

Given IV

Also known as: 5-FU
Arm A- Physician DiscretionArm B- PAGODA Algorithm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \* REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
  • Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract
  • Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)
  • Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin
  • Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted
  • The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)
  • Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration
  • Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg/m\^2) and infusional 5-FU (2400 mg/m\^2/46 hours). Use of the 5-FU bolus is at the discretion of the treating physician
  • Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible
  • History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible
  • Age ≥ 18 years
  • ECOG performance status ≤ 2
  • Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Total bilirubin ≤ 3 x upper limit of normal (ULN)
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (271)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

RECRUITING

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

RECRUITING

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

RECRUITING

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, 93420, United States

RECRUITING

Mercy Cancer Center - Carmichael

Carmichael, California, 95608, United States

RECRUITING

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

RECRUITING

Mercy Cancer Center - Elk Grove

Elk Grove, California, 95758, United States

RECRUITING

Mercy Cancer Center

Merced, California, 95340, United States

RECRUITING

Mercy Cancer Center - Rocklin

Rocklin, California, 95765, United States

RECRUITING

Mercy Cancer Center - Sacramento

Sacramento, California, 95816, United States

RECRUITING

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, 93401, United States

RECRUITING

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, 93444, United States

RECRUITING

Saint Joseph's Medical Center

Stockton, California, 95204, United States

RECRUITING

Woodland Memorial Hospital

Woodland, California, 95695, United States

RECRUITING

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

RECRUITING

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907, United States

RECRUITING

Saint Francis Cancer Center

Colorado Springs, Colorado, 80923, United States

RECRUITING

CommonSpirit Cancer Center Mercy

Durango, Colorado, 81301, United States

RECRUITING

Mercy Medical Center

Durango, Colorado, 81301, United States

RECRUITING

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

RECRUITING

Longmont United Hospital

Longmont, Colorado, 80501, United States

RECRUITING

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

RECRUITING

Saint Anthony North Hospital

Westminster, Colorado, 80023, United States

RECRUITING

Beebe Medical Center

Lewes, Delaware, 19958, United States

RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States

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

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

RECRUITING

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801, United States

RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

RECRUITING

Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States

RECRUITING

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

RECRUITING

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

RECRUITING

SIH Cancer Institute

Carterville, Illinois, 62918, United States

RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

RECRUITING

Saint Mary's Hospital

Centralia, Illinois, 62801, United States

SUSPENDED

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

Illinois CancerCare-Dixon

Dixon, Illinois, 61021, 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

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

RECRUITING

Carle BroMenn Medical Center

Normal, Illinois, 61761, United States

RECRUITING

Carle Cancer Institute Normal

Normal, Illinois, 61761, 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

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

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

RECRUITING

Valley Radiation Oncology

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

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

RECRUITING

Mary Greeley Medical Center

Ames, Iowa, 50010, United States

RECRUITING

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

McFarland Clinic - Boone

Boone, Iowa, 50036, United States

SUSPENDED

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

RECRUITING

Greater Regional Medical Center

Creston, Iowa, 50801, 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

Broadlawns Medical Center

Des Moines, Iowa, 50314, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States

RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States

SUSPENDED

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266, United States

RECRUITING

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846, United States

RECRUITING

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530, United States

RECRUITING

Mercy Hospital Pittsburg

Pittsburg, Kansas, 66762, United States

RECRUITING

Flaget Memorial Hospital

Bardstown, Kentucky, 40004, United States

RECRUITING

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, 40701, United States

RECRUITING

Saint Joseph Hospital

Lexington, Kentucky, 40504, United States

RECRUITING

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, 40504, United States

RECRUITING

Saint Joseph Hospital East

Lexington, Kentucky, 40509, United States

RECRUITING

Saint Joseph London

London, Kentucky, 40741, United States

RECRUITING

Saint Joseph Mount Sterling

Mount Sterling, Kentucky, 40353, United States

RECRUITING

Christiana Care - Union Hospital

Elkton, Maryland, 21921, United States

RECRUITING

MyMichigan Medical Center Gratiot

Alma, Michigan, 48801, United States

RECRUITING

MyMichigan Medical Center Alpena

Alpena, Michigan, 49707, United States

RECRUITING

Trinity Health IHA - Obstetrics and Gynecology West Arbor

Ann Arbor, Michigan, 48103, United States

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, 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

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

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

RECRUITING

Henry Ford River District Hospital

East China Township, Michigan, 48054, United States

RECRUITING

Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States

RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

RECRUITING

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

RECRUITING

Hurley Medical Center

Flint, Michigan, 48503, United States

RECRUITING

MyMichigan Medical Center Gladwin

Gladwin, Michigan, 48624, United States

RECRUITING

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, 48236, United States

RECRUITING

Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, 48236, United States

RECRUITING

Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, 48236, 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 Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States

RECRUITING

Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, 48044, United States

RECRUITING

MyMichigan Medical Center Midland

Midland, Michigan, 48670, United States

RECRUITING

MyMichigan Medical Center Mount Pleasant

Mount Pleasant, Michigan, 48858, United States

RECRUITING

Hope Cancer Center

Pontiac, Michigan, 48341, United States

RECRUITING

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341, United States

RECRUITING

Newland Medical Associates-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 Health Warren Hospital

Warren, Michigan, 48093, United States

RECRUITING

Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, 48093, United States

RECRUITING

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, 48093, United States

RECRUITING

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

RECRUITING

Riverwood Healthcare Center

Aitkin, Minnesota, 56431, United States

RECRUITING

Essentia Health - Baxter Clinic

Baxter, Minnesota, 56425, United States

RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

RECRUITING

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

RECRUITING

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337, United States

RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Essentia Health - Saint Joseph's Crosslake Clinic

Crosslake, Minnesota, 56442, United States

RECRUITING

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

RECRUITING

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

RECRUITING

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, 55805, United States

RECRUITING

Miller-Dwan Hospital

Duluth, Minnesota, 55805, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

RECRUITING

Essentia Health - Ely Clinic

Ely, Minnesota, 55731, United States

RECRUITING

Essentia Health - Fosston

Fosston, Minnesota, 56542, United States

RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

RECRUITING

Essentia Health - International Falls Clinic

International Falls, Minnesota, 56649, United States

RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369, United States

RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Essentia Health - Moose Lake Clinic

Moose Lake, Minnesota, 55767, United States

RECRUITING

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

RECRUITING

Essentia Health - Park Rapids

Park Rapids, Minnesota, 56470, United States

RECRUITING

Essentia Health - Saint Joseph's Pequot Lakes Clinic

Pequot Lakes, Minnesota, 56472, United States

RECRUITING

Essentia Health - Saint Joseph's Pine River Clinic

Pine River, Minnesota, 56474, United States

RECRUITING

Fairview Northland Medical Center

Princeton, Minnesota, 55371, United States

RECRUITING

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

United Hospital

Saint Paul, Minnesota, 55102, United States

RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

RECRUITING

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

RECRUITING

Essentia Health - Saint Joseph's Staples Clinic

Staples, Minnesota, 56479, United States

RECRUITING

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

RECRUITING

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, 56701, United States

RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

RECRUITING

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

RECRUITING

Sanford Cancer Center Worthington

Worthington, Minnesota, 56187, United States

RECRUITING

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092, 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

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, 63011, United States

RECRUITING

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

RECRUITING

Cox Cancer Center Branson

Branson, Missouri, 65616, United States

RECRUITING

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

RECRUITING

Freeman Health System

Joplin, Missouri, 64804, United States

RECRUITING

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, 65065, United States

RECRUITING

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

RECRUITING

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

RECRUITING

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

RECRUITING

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

RECRUITING

Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States

RECRUITING

Mercy Hospital South

St Louis, Missouri, 63128, United States

RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

RECRUITING

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

RECRUITING

Mercy Hospital Washington

Washington, Missouri, 63090, United States

RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

RECRUITING

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

RECRUITING

Great Falls Clinic

Great Falls, Montana, 59405, United States

RECRUITING

Hi-Line Sletten Cancer Center

Havre, Montana, 59501, United States

RECRUITING

Benefis Helena Specialty Center

Helena, Montana, 59601, United States

RECRUITING

Logan Health Medical Center

Kalispell, Montana, 59901, United States

RECRUITING

Community Medical Center

Missoula, Montana, 59804, United States

RECRUITING

CHI Health Saint Francis

Grand Island, Nebraska, 68803, United States

RECRUITING

CHI Health Good Samaritan

Kearney, Nebraska, 68847, United States

RECRUITING

Alegent Health Immanuel Medical Center

Omaha, Nebraska, 68122, United States

RECRUITING

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

RECRUITING

Alegent Health Lakeside Hospital

Omaha, Nebraska, 68130, United States

RECRUITING

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

RECRUITING

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103, United States

RECRUITING

Sanford South University Medical Center

Fargo, North Dakota, 58103, United States

RECRUITING

Southpointe-Sanford Medical Center Fargo

Fargo, North Dakota, 58103, United States

RECRUITING

Sanford Medical Center Fargo

Fargo, North Dakota, 58104, 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

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, 58401, United States

RECRUITING

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

RECRUITING

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

RECRUITING

TriHealth Cancer Institute-Westside

Cincinnati, Ohio, 45247, United States

RECRUITING

TriHealth Cancer Institute-Anderson

Cincinnati, Ohio, 45255, United States

RECRUITING

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Baker City

Baker City, Oregon, 97814, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States

RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

RECRUITING

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

RECRUITING

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

RECRUITING

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201, United States

RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

RECRUITING

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

RECRUITING

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, 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

Saint Michael Cancer Center

Silverdale, Washington, 98383, United States

RECRUITING

Duluth Clinic Ashland

Ashland, Wisconsin, 54806, United States

RECRUITING

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, 54806, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

Essentia Health-Hayward Clinic

Hayward, Wisconsin, 54843, United States

RECRUITING

Tamarack Health Hayward Medical Center

Hayward, Wisconsin, 54843, United States

RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081, United States

RECRUITING

Sheboygan Physicians Group

Sheboygan, Wisconsin, 53081, United States

RECRUITING

Essentia Health-Spooner Clinic

Spooner, Wisconsin, 54801, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495, United States

RECRUITING

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, 54880, United States

RECRUITING

Memorial Hospital of Laramie County

Cheyenne, Wyoming, 82001, United States

RECRUITING

Billings Clinic-Cody

Cody, Wyoming, 82414, United States

RECRUITING

MeSH Terms

Conditions

Appendiceal NeoplasmsColonic NeoplasmsEsophageal NeoplasmsStomach NeoplasmsGastrointestinal NeoplasmsRectal Neoplasms

Interventions

OxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Cecal NeoplasmsIntestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesColorectal NeoplasmsColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Gabriel A. Brooks, MD, MPH

    Alliance for Clinical Trials in Oncology

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 16, 2025

Study Start

February 13, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 2, 2030

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations