Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer
OBJECTIVES:
Phase II:
- Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine
vs gemcitabine alone after prior curative resection in patients with pancreatic head
adenocarcinoma.
- Compare the tolerability of these regimens, in terms of acute and late toxicity, in
these patients.
Phase III:
- Compare the disease-free and overall survival of patients treated with these regimens .
- Compare the quality of life of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Determine the sites of recurrence in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
ECOG/WHO performance status (0-1 vs 2), participating center, and N stage (N0 vs N1 vs NX).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 8 weeks after prior surgical resection, patients receive gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses.
Patients then receive additional gemcitabine IV over 30 minutes on days 57, 64, 71, 78, 85,
and 92. Beginning on day 57, patients also undergo radiotherapy once daily, 5 days a week,
for 6 weeks. Treatment continues in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment
repeats every 4 weeks for 4 courses.
Quality of life (QOL) is assessed in both arms, according to the following schedules:
- Arm I: QOL is assessed at baseline; at 3 weeks after the beginning of
chemoradiotherapy; after the completion of chemoradiotherapy; every 3 months for 2
years; and then every 6 months for 1 year.
- Arm II: QOL is assessed at baseline; at 12 weeks; at 16 weeks; every 3 months for 2
years; and then every 6 months for 1 year.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 538 patients (269 per treatment arm) will be accrued for this
study within 3 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
No
Jean-Luc Van Laethem, MD, PhD
Study Chair
Hopital Universitaire Erasme
United States: Federal Government
EORTC-40013-22012
NCT00064207
May 2003
Name | Location |
---|