Clinical trialPhase 3Completed
Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
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
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- 14 August 2013
- Expected end
- 30 September 2022
- Enrollment
- 27 participants
- Sites
- 9
- Primary outcomes
- Progression-free Survival (PFS)
- Sponsor
- Other
- Results posted
- 2022-10-28
- Last update
- 28 October 2022
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [38 months]. Median, months (Standard Deviation). Modified FOLFIRINOX (n=13): 6.5 (6.6); Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 8.4 (9.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Local Progression-free Survival (Local PFS) [38 months]. Median, months (Standard Deviation). Modified FOLFIRINOX (n=13): 6.5 (6.6); Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 8.4 (10.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) at 1 Year [1 year]. Count Of Participants, Participants. Modified FOLFIRINOX (n=13): 5; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Metastasis-free Survival (MFS) [62 months]. Median, months (Standard Deviation). Modified FOLFIRINOX (n=13): 12.9 (6.4); Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 10.8 (16.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [62 months]. Median, months (Standard Deviation). Modified FOLFIRINOX (n=13): 12.9 (6.4); Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 13.4 (16.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Grade 2 or Greater Gastrointestinal (GI) Toxicity [3 months]. Number, Related adverse events. Blood in stool (melena): Modified FOLFIRINOX (n=13): 1; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 0. Colitis: Modified FOLFIRINOX (n=13): 1; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 0. Colonic obstruction: Modified FOLFIRINOX (n=13): 1; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 0. Diarrhea: Modified FOLFIRINOX (n=13): 3; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 0. Duodenal perforation: Modified FOLFIRINOX (n=13): 0; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 1. Fistula, anal: Modified FOLFIRINOX (n=13): 0; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 3. Fluid in abdomen (ascites): Modified FOLFIRINOX (n=13): 0; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 2. Gastrointestinal bleed (hemorrhage): Modified FOLFIRINOX (n=13): 1; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 1. Gastrointestinal bleed (hemorrhage), upper: Modified FOLFIRINOX (n=13): 0; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 3. Gastrointestinal inflammation (enterocolitis): Modified FOLFIRINOX (n=13): 1; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 0. Nausea: Modified FOLFIRINOX (n=13): 3; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 1. Pain, abdominal: Modified FOLFIRINOX (n=13): 3; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 4. Pain, intractable (due to disease progression): Modified FOLFIRINOX (n=13): 0; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 1. Stool discolored, clay color: Modified FOLFIRINOX (n=13): 1; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 0. Vomited blood (hematemesis): Modified FOLFIRINOX (n=13): 0; Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy (n=12): 4.