Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

Program Overview

This phase III trial is comparing the effects of higher dose radiation therapy to the usual care in patients with locally advanced pancreatic cancer that cannot be surgically removed. Usual care options include more chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may slow tumor growth but have not been proven to extend life. Radiation therapy uses high-energy X-rays to kill cancer cells and shrink tumors. The higher dose radiation therapy involves delivering more intense doses directly to the tumor, often over a shorter time. This trial aims to see if this approach can help patients live longer.

Description

The main goal of this study is to find out if higher dose radiation therapy can improve survival rates over three years compared to standard treatments in patients with locally advanced pancreatic cancer who have not shown disease progression and have responded to initial chemotherapy.

Secondary goals include comparing how well the cancer is controlled locally, how long patients live without the cancer getting worse, and how long they can go without needing more chemotherapy. The study will also look at the side effects of the treatments and how they affect patients' quality of life.

Patients will be randomly assigned to one of two groups:

• Standard Care Group: Patients will receive one of three treatment options based on their doctor's decision:

  1. Continue chemotherapy with drugs like FOLFIRINOX or gemcitabine/nab-paclitaxel for a total of 6 months, with the possibility of continuing beyond 6 months.
  2. Undergo standard dose radiation therapy once a day for 28 or 30 sessions, along with chemotherapy drugs like fluorouracil or capecitabine. After radiation, patients who haven't completed 6 months of chemotherapy will be encouraged to do so.
  3. Be observed without additional treatment, recommended for those who have already completed 6 months of chemotherapy.

• Higher Dose Radiation Group: Patients will receive higher dose radiation therapy either daily, every other day, or twice a week for 5 sessions, or daily for 25 sessions, possibly with chemotherapy drugs like fluorouracil or capecitabine. After radiation, patients who haven't completed 6 months of chemotherapy will be encouraged to do so.

Throughout the study, patients will have blood samples taken, and undergo CT, MRI scans, and tumor biopsies. They will be followed every 3 months for 2 years, then annually for 3 years.

Eligibility Criteria

Locations