Trial Information

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.