Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborator: Federation Francophone de Cancerologie Digestive
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed pancreatic head adenocarcinoma

• Prior pancreaticoduodenectomy required

• Documented histological examination of surgical margins (R0), including retroperitoneal margin

• Performed within the past 8 weeks

• Any number of lymph nodes (less than 10 OR 10 or more) allowed

• No periampullary cancer

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,500/mm^3

• Platelet count greater than 150,000/mm^3

• Hemoglobin greater than 9.0 g/dL

Hepatic

• Bilirubin less than 1.5 times normal

• AST and ALT less than 3.0 times normal

Renal

• Creatinine less than 1.2 mg/dL

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix

• No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

• Recovered from prior surgery

Other

• No other concurrent anticancer agents