Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

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 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.

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

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Capecitabine

Given capecitabine

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

RADIATION

Dose-escalated Radiation Therapy

Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning

DRUG

Fluorouracil

Given fluorouracil

DRUG

Gemcitabine

Given gemcitabine

DRUG

Irinotecan Hydrochloride

Given irinotecan hydrochloride

DRUG

Irinotecan Sucrosofate

Given liposomal irinotecan

DRUG

Leucovorin Calcium

Given leucovorin calcium

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Nab-paclitaxel

Given nab-paclitaxel

OTHER

Observation Activity

Undergo observation

DRUG

Oxaliplatin

Given oxaliplatin

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo standard radiation therapy

Sponsors & Collaborators

• NRG Oncology

  lead OTHER

Principal Investigators

• Nina N Sanford · NRG Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-21

Primary Completion

2030-10-21

Completion

2030-10-21

Countries

• United States

Study Locations