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Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer: A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial

Clinical Trial Summary

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.

Clinical Trial Description

Primary Objective: To determine progression free survival for mFFX +/- SBRT. Secondary Objectives: - To determine metastasis free survival following mFFX chemotherapy alone or with SBRT. - To determine the overall survival in pancreatic cancer patients treated with chemotherapy +/- SBRT. - To determine local progression-free survival in pancreatic cancer patients after chemotherapy +/- SBRT. - To evaluate acute (within 3 months of treatment) grade 2 or greater gastritis, fistula, enteritis, or ulcer and any other grade 3-4 gastrointestinal toxicity within 3 months of treatment. - To evaluate the utility of FDG-PET for treatment planning and estimation of progression free survival. - To identify new biomarkers in pancreatic cancer. - To evaluate the quality of life of patients before and after either chemotherapy or chemotherapy and SBRT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01926197
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase Phase 3
Start date August 14, 2013
Completion date September 30, 2022
View Details
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