• Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II [ Designated as safety issue: No ]
  
• Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II [ Designated as safety issue: Yes ]
  
• Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II [ Designated as safety issue: Yes ]
  
• Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III [ Designated as safety issue: No ]
  

• Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter [ Designated as safety issue: No ]
  
• Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter [ Designated as safety issue: Yes ]
  
• Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter [ Designated as safety issue: Yes ]
  
• Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) v3.0 and EORTC QLQ PAN-26 every 3 months in years 1-2 and every 6 months thereafter [ Designated as safety issue: No ]
  

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.