Trial Search Results

Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Oxaliplatin
  • Radiation: SBRT
  • Drug: Irinotecan
  • Drug: Leucovorin
  • Drug: 5FU

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed adenocarcinoma of the pancreas.

   - Induction mFolfirinox up to 4 cycles. Informed consent must be signed by the end of
   the second cycle.

   - Stable or better disease on re-staging scans.

   - Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or
   gastrointestinal oncology Tumor Board.

   - Typically, pancreatic tumors must be less than 8.0 cm in greatest axial dimension at
   the time of treatment planning but final determination of eligibility will be based
   upon satisfying the radiation normal tissue constraints as per protocol.

   - ECOG 0, 1, or 2

   - Patients must have acceptable organ and marrow function as defined below and within 30
   days of eligibility confirmation:

      - leukocytes (WBC) >=3,000/mL

      - absolute neutrophil count (ANC)>=1,500mL

      - platelets >=50,000/mL

      - total bilirubin < or = 1.5 X institutional upper limit of normal

      - AST(SGOT)/ALT(SGPT) < or =2.5 X institutional upper limit of normal

      - 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

   - Patients who have had prior radiotherapy to the upper abdomen/liver.

   - Patients who have received chemotherapy for pancreatic cancer, other than up to 4
   cycles of mFolfirinox.

   - Children are excluded because pancreatic tumors rarely occur in this age group.
   Furthermore, treatment requires a great deal of patient cooperation including the
   ability to lie still for several hours in an isolated room.

   - 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, or 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 and breastfeeding women are excluded; as well as 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) to avoid pregnancy for the
   duration of the study. Male subjects must also agree to use effective contraception
   for the same period as above. Should a woman become pregnant or suspect she is
   pregnant while participating in this study, she should inform her treating physician
   immediately.

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Samantha Wong
650-498-8495
Recruiting