Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo tumor tissue biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Capecitabine — DRUG
  Given capecitabine
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• Dose-escalated Radiation Therapy — RADIATION
  Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning
• Fluorouracil — DRUG
  Given fluorouracil
• Gemcitabine — DRUG
  Given gemcitabine
• Irinotecan Hydrochloride — DRUG
  Given irinotecan hydrochloride
• Irinotecan Sucrosofate — DRUG
  Given liposomal irinotecan
• Leucovorin Calcium — DRUG
  Given leucovorin calcium
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nab-paclitaxel — DRUG
  Given nab-paclitaxel
• Observation Activity — OTHER
  Undergo observation
• Oxaliplatin — DRUG
  Given oxaliplatin
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Questionnaire Administration — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Undergo standard radiation therapy

Study Details

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 Dates

Start date

Aug 21, 2025

Status verified

Apr 2026

Primary completion

Oct 21, 2030

Completion

Oct 21, 2030

Study Design

Enrollment

356 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (Options 1, 2, or 3)
  See Detailed Description.
• Experimental: Arm II (dose-escalated RT)
  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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From randomization to the date of death or last follow-up, assessed up to 3 years ]

Locations (279)

Find similar trials in Gilbert, AZ

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