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

Completed · Phase 3

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01926197

Run by

Stanford University

People needed

27

Starts

2013-08-14

Expected to finish

2022-09-30

Last updated by the study team

2022-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA — Los Angeles, California, United States
• UCSF — San Francisco, California, United States
• Stanford University, School of Medicine — Stanford, California, United States
• Loyola University — Maywood, Illinois, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• BC Cancer Agency — Vancouver, British Columbia, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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