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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oxaliplatin
Irinotecan
Leucovorin
5FU
Stereotactic Body Radiotherapy (SBRT)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  • Histologically-confirmed adenocarcinoma of the pancreas
  • Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
  • Stable or better disease on re-staging scans
  • Typically, tumors < 8.0 cm in greatest axial dimension but final determination of eligibility based upon radiation normal tissue constraints
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
  • Leukocytes (white blood cells, WBC) ≥ 3,000/mL
  • Absolute neutrophil count (ANC) ≥ 1,500/mL
  • Platelets ≥ 50,000/mL
  • Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 X institutional ULN
  • Creatinine within normal institutional limits
  • Ability to understand and the willingness to sign an informed consent form
  • Life expectancy > 6 months

EXCLUSION CRITERIA

  • Metastatic disease
  • Prior radiotherapy to the upper abdomen/liver.
  • Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified FOLFIRINOX.
  • Age < 18 years

  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection (or infections requiring systemic antibiotic treatment)
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.
  • Pregnant or lactating
  • Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) for duration of the study
  • Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
  • Male subjects who are unwilling or unable to use effective contraception for duration of the study

Sites / Locations

  • UCLA
  • UCSF
  • Stanford University, School of Medicine
  • Loyola University
  • Medical University of South Carolina
  • University of Texas Southwestern Medical Center
  • Swedish Cancer Institute
  • BC Cancer Agency
  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Modified FOLFIRINOX

Modified FOLFIRINOX plus Stereotactic Body Radiotherapy

Arm Description

Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.

Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
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

Local Progression-free Survival (Local PFS)
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
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.
Metastasis-free Survival (MFS)
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)
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.
Grade 2 or Greater Gastrointestinal (GI) Toxicity
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

Full Information

First Posted
August 15, 2013
Last Updated
October 3, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01926197
Brief Title
Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 14, 2013 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified FOLFIRINOX
Arm Type
Active Comparator
Arm Description
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
Arm Title
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
Arm Type
Experimental
Arm Description
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar, Camptothecin-11 (CPT-11), Campto, Onivyde
Intervention Description
Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Folinic acid, Wellcovorin, Citrovorum Factor
Intervention Description
Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.
Intervention Type
Drug
Intervention Name(s)
5FU
Other Intervention Name(s)
5-fluorouracil, Tolak, Fluoroplex, Efudex, Carac, Adrucil
Intervention Description
5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
38 months
Secondary Outcome Measure Information:
Title
Local Progression-free Survival (Local PFS)
Description
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.
Time Frame
38 months
Title
Progression-free Survival (PFS) at 1 Year
Description
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.
Time Frame
1 year
Title
Metastasis-free Survival (MFS)
Description
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.
Time Frame
62 months
Title
Overall Survival (OS)
Description
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.
Time Frame
62 months
Title
Grade 2 or Greater Gastrointestinal (GI) Toxicity
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Histologically-confirmed adenocarcinoma of the pancreas Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board. Stable or better disease on re-staging scans Typically, tumors < 8.0 cm in greatest axial dimension but final determination of eligibility based upon radiation normal tissue constraints Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2 Leukocytes (white blood cells, WBC) ≥ 3,000/mL Absolute neutrophil count (ANC) ≥ 1,500/mL Platelets ≥ 50,000/mL Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 X institutional ULN Creatinine within normal institutional limits Ability to understand and the willingness to sign an informed consent form Life expectancy > 6 months EXCLUSION CRITERIA Metastatic disease Prior radiotherapy to the upper abdomen/liver. Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified FOLFIRINOX. Age < 18 years Uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection (or infections requiring systemic antibiotic treatment) Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness/social situations that would limit compliance with study requirements. Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial. Pregnant or lactating Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) for duration of the study Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test Male subjects who are unwilling or unable to use effective contraception for duration of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel T Chang
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
60153
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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