Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery.

PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.

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

Details

• Lead Sponsor: Royal Liverpool University Hospital
• Collaborators: Australasian Gastro-Intestinal Trials Group; NCIC Clinical Trials Group
• Treatments: Calcium; Fluorouracil; Gemcitabine; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ductal adenocarcinoma of the pancreas OR

• Histologically confirmed diagnosis of 1 of the following types of cancer:

• Acinar cell carcinoma or cystadenocarcinoma of the pancreas

• Cancers of the periampullary region

• Cancers of the intrapancreatic part of the bile duct

• Periampullary cancers of uncertain origin

• Complete macroscopic resection (R0 or R1 resection)

• Histological examination of all resection margins required

• No stage IVB disease

• No evidence of malignant ascites

• No liver or peritoneal metastases

• No evidence of spread to other distant abdominal or extra-abdominal organs

• No pancreatic lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant

• Able to participate in long-term follow-up

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

• No serious medical or psychological condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No neoadjuvant chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

• Recovered from prior resection