Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

Recruiting now · Phase 3

Conditions studied: Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT06958328

Run by

NRG Oncology

People needed

356

Starts

2025-08-21

Expected to finish

2030-10-21

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted
• If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford
• POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:
• If baseline CA19-9 is elevated (defined as > 37 u/mL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u/mL or a 50% decline from pre-chemotherapy level with absolute value less than 100u/mL
• If baseline CA19-9 is not elevated (defined as ≤ 37 u/mL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u/mL
• No active duodenal or gastric ulcers
• No direct tumor invasion of the bowel or stomach
• Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, or CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to enrollment, with restaging CT showing at least stable disease
• Not pregnant and not nursing
• No cardiac condition that was the primary reason for hospitalization in the last 6 months

Where it is running

• Arizona Center for Cancer Care - Gilbert — Gilbert, Arizona, United States (enrolling)
• Arizona Center for Cancer Care-Peoria — Peoria, Arizona, United States (enrolling)
• Arizona Center for Cancer Care - Phoenix — Phoenix, Arizona, United States (enrolling)
• Arizona Center for Cancer Care - Scottsdale — Scottsdale, Arizona, United States (enrolling)
• Arizona Center for Cancer Care-Surprise — Surprise, Arizona, United States (enrolling)
• Arizona Center for Cancer Care — Tempe, Arizona, United States (enrolling)
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States (enrolling)
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States (enrolling)
• Mills-Peninsula Medical Center — Burlingame, California, United States (enrolling)
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States (enrolling)
• Palo Alto Medical Foundation-Fremont — Fremont, California, United States (enrolling)
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Memorial Medical Center — Modesto, California, United States (enrolling)
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States (enrolling)
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States (enrolling)
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States (enrolling)
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States (enrolling)
• Sutter Roseville Medical Center — Roseville, California, United States (enrolling)
• Sutter Medical Center Sacramento — Sacramento, California, United States (enrolling)
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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