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

Not Recruiting

Trial ID: NCT01926197


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.

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



   - 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


   - Metastatic disease

   - Prior radiotherapy to the upper abdomen/liver.

   - Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified

   - Age < 18 years

   - Uncontrolled intercurrent illness including, but not limited to:

      - Ongoing or active infection (or infections requiring systemic antibiotic

      - Symptomatic congestive heart failure

      - Unstable angina pectoris

      - Cardiac arrhythmia

      - Psychiatric illness/social situations that would limit compliance with study

   - 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


drug: Oxaliplatin

drug: Irinotecan

drug: Leucovorin

drug: 5FU

radiation: Stereotactic Body Radiotherapy (SBRT)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Samantha Wong

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