MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer

NCT01972919 | Active Not Recruiting Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 17687
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is for people who have pancreas cancer for which surgery is not recommended. Potential patients must have already received several months of chemotherapy before they are eligible for this study and there will not have been any detectable spread of their tumor on imaging studies following this chemotherapy course.

Conditions

Unresectable Pancreatic Cancer

Keywords

Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  This measure will be the number of subjects alive at one and two years following the end of radiation treatment, up to two years and seven weeks.

  1 and 2 years following up to 7 weeks of radiation treatment

Secondary Outcomes (7)

• Radiographic Response

  Baseline and 1 year

• Serum Cancer Antigen 19-9 (CA19-9)

  Baseline and 1 year

• Serum Carcinoembryonic Antigen (CEA)

  Baseline and 1 year

• Radiation Induced Toxicity

  3 months post treatment

• SMAD 4 Expression

  Baseline

Study Arms (1)

Radiation therapy plus chemotherapy

EXPERIMENTAL

MR guided dose escalated radiation therapy plus concurrent chemotherapy in unresectable non-metastatic pancreas cancer. Radiation therapy dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction and concurrent Gemcitabine or Capecitabine.

Radiation: Radiation Therapy; Drug: Concurrent chemotherapy (Gemcitabine, Capecitabine)

Interventions

Radiation Therapy RADIATION

Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction.

Also known as: Dose escalation radiation therapy

Radiation therapy plus chemotherapy

Concurrent chemotherapy (Gemcitabine, Capecitabine) DRUG

Gemcitabine 400mg/m\^2 IV weekly x 6 doses. Capecitabine 825 mg/m\^2 by mouth twice daily Monday-Friday on days of radiation use 500 mg tablets.

Also known as: Gemzar, Xeloda

Radiation therapy plus chemotherapy

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed (histologic or cytologic), locally advanced, adenocarcinoma of the pancreas; patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability.
• Participants with and without regional adenopathy are eligible.
• No distant metastases, based upon the following minimum diagnostic workup:
• History/physical examination, including collection of weight and vital signs, within 28 days prior to study entry;
• Abdominal/pelvic CT scan with IV contrast within 21 days prior to study entry;
• Chest CT scan, or X-ray within 21 days prior to study entry.
• Abdominal/pelvic MR prior to radiation with perfusion and diffusion- weighted sequences and MR and CT sim for radiation planning Pet scan within 21 days prior to study entry, Functional renal study.
• Zubrod performance status 0-1 within 1 week of study entry.
• Age ≥ 18.
• Hematology and cancer antigen (CA) 19-9 / carcinoembryonic antigen (CEA) within 14 days prior to study entry, as follows.
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3;
• Platelets ≥ 100,000 cells/mm\^3;
• Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
• Serum creatinine ≤ 1.5 mg/dl;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x upper limit of normal (ULN);

You may not qualify if:

• Distant metastatic disease, second malignancy or peritoneal seeding;
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Any major surgery within 28 days prior to study entry
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• Transmural myocardial infarction within 3 months prior to study entry;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration;
• Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function;
• Any unresolved bowel or bile duct obstruction;
• Major resection of the stomach or small bowel that could affect the absorption of capecitabine
• Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition;
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women, for 3 months after the last study drug administration.
• Women who are lactating at the time of registration and who plan to be lactating through 3 months after the last study drug administration.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy; Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Beth Erickson, MD
• Organization: Medical College of Wisconsin

BErickson@mcw.edu

414-805-4462

Study Officials

• Beth Erickson, MD

  Froedtert & The Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: October 31, 2013
• Study Start: December 10, 2015
• Primary Completion: December 13, 2023
• Study Completion: March 1, 2026
• Last Updated: October 27, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)