Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
- Confirm the value of chronomodulated infusion with respect to survival in patients with
locally advanced or metastatic pancreatic cancer.
- Test the value of adding cisplatin to fluorouracil in extending survival in these
OUTLINE: This is a multicenter, randomized study.
The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment
groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in
each of the 4 groups is repeated for 3 courses where each course is a 5-day course of
Patients in the first group receive a chronomodulated schedule based on delivery of
fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and
CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU
alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses
whereas dosages of CDDP remain constant.
Treatment is continued until disease progression, severe toxicity, or complete remission for
more than 4 months occurs.
PROJECTED ACCRUAL: 200 patients will be accrued.
Allocation: Randomized, Primary Purpose: Treatment
Francis Levi, MD, PhD
Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
United States: Federal Government