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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00058201
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : December 18, 2013
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Australasian Gastro-Intestinal Trials Group
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Other: clinical observation Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1030 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: European Study Group For Pancreatic Cancer - Trial 3
Study Start Date : July 2001
Actual Primary Completion Date : April 2008
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
 Drug: fluorouracil
Given IV

Drug: leucovorin calcium
Given IV
Experimental: Arm II
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
 Drug: gemcitabine hydrochloride
Given IV
No Intervention: Arm III
Patients undergo observation.
 Other: clinical observation
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Toxicity as measured by NCI CTC v2.0
  2. 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
  3. Survival rate at 2 and 5 years

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058201


Locations
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Sponsors and Collaborators
Royal Liverpool University Hospital
NCIC Clinical Trials Group
Australasian Gastro-Intestinal Trials Group
Investigators
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Study Chair: John P. Neoptolemos, MD Royal Liverpool University Hospital
Study Chair: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
OverallOfficial: R. Padbury Flinders Medical Centre
OverallOfficial: David Goldstein, MD Institute of Oncology at Prince of Wales Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00058201    
Other Study ID Numbers: CDR0000287023
RLUH-NCRI-ESPAC-3V2
EU-20043
CAN-NCIC-PA2
AGITG-ESPAC-3
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: May 2008
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:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Gemcitabine
Fluorouracil
Calcium
Levoleucovorin
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients