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

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU; Radiation: Stereotactic Body Radiotherapy (SBRT)

• Registration Number: NCT01926197
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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 Timeline

• Study Start: 2013-08-14
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Primary Completion: 2021-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Results First Submitted: 2022-10-03
• Results First Submitted QC: 2022-10-03
• Last Update Submitted: 2022-10-03
• Results First Posted: 2022-10-28
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy	5FU	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
Modified FOLFIRINOX	Irinotecan	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
Modified FOLFIRINOX	5FU	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy	Stereotactic Body Radiotherapy (SBRT)	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy	Irinotecan	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
Modified FOLFIRINOX	Oxaliplatin	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
Modified FOLFIRINOX	Leucovorin	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy	Oxaliplatin	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy	Leucovorin	Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	38 months	Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.

Secondary Outcome Measures

Name	Time	Method
Local Progression-free Survival (Local PFS)	38 months	Local progression-free survival (PFS) means the period of time that a participant remains alive without recurrence or advancement of the disease at the baseline sites of the tumor (local progression). The effect of the study treatments was assessed as the median local PFS of participants in the treatment groups. The outcome is reported as the median local PFS with standard deviation.
Progression-free Survival (PFS) at 1 Year	1 year	Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the number of participants in each treatment group that remained alive without tumor progression, at 1 year after treatment.; The outcome is reported as a number without dispersion.
Grade 2 or Greater Gastrointestinal (GI) Toxicity	3 months	Toxicity means an adverse event related to the study treatment. Toxicity was assessed between treatment groups as the number of treatment-related , ≥ grade 2 events of gastritis, fistula, enteritis, or ulcer; plus any other Grade 3 to 5 gastrointestinal (GI) toxicity. The outcome is reported as the number of defined adverse events by preferred term for each treatment group, occurring within 3 months of the start of treatment. These adverse events by definition are all within the Common Terminology Criteria for Adverse Events (CTCAE) version 4.01 Gastrointestinal Body System. The outcome is reported as numbers without dispersion.; All-cause Mortality mFFX 7 SBRT 8
Metastasis-free Survival (MFS)	62 months	Metastasis-free survival (MFS) means the period of time that a participant remains alive without the appearance of new tumor lesions a distant site in the body (metastasis). The effect of the study treatments was assessed as the median MFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Overall Survival (OS)	62 months	The effect of the study treatments was assessed as the length of time participants in each treatment group that remained alive. The outcome is reported as the median OS with standard deviation.

Trial Locations

Locations (9)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Loyola University; 🇺🇸 Maywood, Illinois, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

BC Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

UCSF; 🇺🇸 San Francisco, California, United States