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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Adjuvant Study of Gemcitabine Versus Fluorouracil and Leucovorin Calcium Versus Observation in Patients With Completely Resected Pancreatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	RLUH-NCRI-ESPAC-3V2 EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3, NCT00058201, PA2

Trial Description

Purpose:

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.

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

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No liver metastases or peritoneal metastases
• No distant cancer
• No pancreatic lymphoma
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Some patients will be assigned to a third group and will undergo observation. Patients in group one will receive infusions of leucovorin and fluorouracil on days 1-5. Patients in group two will receive an infusion of gemcitabine once a week for 3 weeks. Treatment in both groups may be repeated every 4 weeks for up to six courses.

Quality of life will be assessed at the beginning of the study, at 3, 6, and 12 months, and once a year for 5 years. Patients will be evaluated every 3 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Royal Liverpool University Hospital

John Neoptolemos, MD, Protocol chair		Ph: 44-151-706-4175 Email: j.p.neoptolemos@liv.ac.uk

NCIC-Clinical Trials Group

Malcolm Moore, MD, Protocol chair		Ph: 416-946-2263

Australasian Gastro-Intestinal Trials Group

R. Padbury, Study coordinator		Ph: 61-8-8204-4523
David Goldstein, MD, Study coordinator		Ph: 61-2-9382-2577 Email: d.goldstein@unsw.edu.au

Registry Information
Official Title		European Study Group For Pancreatic Cancer - Trial 3
Trial Start Date		2001-07-07
Trial Completion Date		2008-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00058201
Date Submitted to PDQ		2003-02-21
Information Last Verified		2008-05-20

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