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

Pancreatic Cancer Clinical Trial

Official title:

European Study Group For Pancreatic Cancer - Trial 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058201
• Other study ID #: CDR0000287023
• Secondary ID: RLUH-NCRI-ESPAC-
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2003
• Last updated: December 17, 2013
• Start date: July 2001
• Est. completion date: September 2010

Study information

• Verified date: May 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium (vs observation only in patients with ampullary or other pancreatic malignancy), in terms of overall survival, in patients with completely resected pancreatic cancer.

Secondary

• Compare the toxicity of these regimens in these patients.

• Compare the quality of life and 5-year survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (ductal adenocarcinoma vs ampullary or other pancreatic malignancy), resection margin status, and participating country. Patients are randomized to 1 of 2 treatment arms. Randomization for patients with ampullary or other pancreatic malignancy includes an observation arm.

• Arm I: Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.

• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.

• Arm III (patients with ampullary or other pancreatic malignancy only): Patients undergo observation.

Treatment in arms I and II repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 3, 6, and 12 months, and then annually for 5 years.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,030 patients with pancreatic adenocarcinoma (515 per arms I and II) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: September 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• fluorouracil
Given IV
• gemcitabine hydrochloride
Given IV
• leucovorin calcium
Given IV

Other:
• clinical observation
No intervention

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Institute of Oncology at Prince of Wales Hospital	Randwick	New South Wales
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
Canada	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	Cancer Research Institute at Queen's University	Kingston	Ontario
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	McGill Cancer Centre at McGill University	Montreal	Quebec
Canada	Ottawa Hospital Regional Cancer Centre - General Campus	Ottawa	Ontario
Canada	Edmond Odette Cancer Centre at Sunnybrook	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	St. Joseph's Health Centre - Toronto	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Island Centre	Victoria	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Czech Republic	Institute for Clinical and Experimental Medicine	Preha 4
Finland	Tampere University Hospital	Tampere
France	Hopital Tenon	Paris
Germany	Universitaets-Kinderklinik Heidelberg	Heidelberg
Greece	Agia Olga Hospital	Athens
Hungary	Petz Aladar County Hospital	Gydr
Italy	Policlinico Borgo Roma	Verona
Japan	Kyoto University Hospital	Kyoto
Sweden	Uppsala University Hospital	Uppsala
Switzerland	Inselspital Bern	Bern
United Kingdom	Royal Liverpool University Hospital	Liverpool	England

Sponsors (3)

Lead Sponsor	Collaborator
Royal Liverpool University Hospital	Australasian Gastro-Intestinal Trials Group, Canadian Cancer Trials Group

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (2)

Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Oláh A, Rawcliffe CL, Verbeke CS, Cam — View Citation

Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Toxicity as measured by NCI CTC v2.0			Yes
Secondary	Quality of life as measured by EORTC QLQ C-30 and ESPAC-QLQ at 3, 6, and 12 months, and then annually for 5 years			No
Secondary	Survival rate at 2 and 5 years			No