Status:
RECRUITING
Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
Lead Sponsor:
NRG Oncology
Conditions:
Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate whether dose-escalated radiation therapy (RT) improves 3-year overall survival (OS) compared to standard treatments without dose-escalated RT, in locally advanced pa...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX (8-12 cycles) or NALIRIFOX (8-12 cycles) or gemcitabine/nab-paclitaxel (4-6 cycles) (1 regimen, no sequential chemotherapy). "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, or CT chest/CT pelvis/MRI abdomen performed prior to enrollment
- Age ≥ 18 years
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Baseline CA19-9 with a normal bilirubin level (defined as ≤ 1.2 mg/dl)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)
- 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 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
- New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Exclusion
Key Trial Info
Start Date :
August 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 21 2030
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT06958328
Start Date
August 21 2025
End Date
October 21 2030
Last Update
November 10 2025
Active Locations (186)
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1
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States, 85297
2
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States, 85381
3
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, United States, 85027
4
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, United States, 85258