Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer - Full Text View

Sponsor:	Royal Liverpool University Hospital
Collaborators:	NCIC Clinical Trials Group Australasian Gastro-Intestinal Trials Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058201

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Procedure: observation	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	European Study Group For Pancreatic Cancer - Trial 3

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Gemcitabine Gemcitabine hydrochloride Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity as measured by NCI CTC v2.0 [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: No ]
Survival rate at 2 and 5 years [ Designated as safety issue: No ]

Estimated Enrollment:	1030
Study Start Date:	July 2001
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.	Drug: fluorouracil Given IV Drug: leucovorin calcium Given IV
Arm II: Experimental Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.	Drug: gemcitabine hydrochloride Given IV
Arm III: No Intervention Patients undergo observation.	Procedure: observation No intervention

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058201

Show 27 Study Locations

Sponsors and Collaborators

Royal Liverpool University Hospital

NCIC Clinical Trials Group

Australasian Gastro-Intestinal Trials Group

Investigators

Study Chair:	John P. Neoptolemos, MD	Royal Liverpool University Hospital
Study Chair:	Malcolm J. Moore, MD	Princess Margaret Hospital, Canada
Investigator:	R. Padbury	Flinders Medical Centre
Investigator:	David Goldstein, MD	Institute of Oncology at Prince of Wales Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000287023, RLUH-NCRI-ESPAC-3V2, EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3
Study First Received:	April 7, 2003
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00058201 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

acinar cell adenocarcinoma of the pancreas
duct cell adenocarcinoma of the pancreas
stage I pancreatic cancer

stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Leucovorin
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients
Gemcitabine

Endocrine Gland Neoplasms
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Fluorouracil
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009