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

This study has been completed.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Australasian Gastro-Intestinal Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00058201
First received: April 7, 2003
Last updated: December 17, 2013
Last verified: May 2008
  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
Other: clinical observation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: European Study Group For Pancreatic Cancer - Trial 3

Resource links provided by NLM:


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
Study Completion Date: September 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
ClinicalTrials.gov Identifier: NCT00058201     History of Changes
Other Study ID Numbers: CDR0000287023, RLUH-NCRI-ESPAC-3V2, EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3
Study First Received: April 7, 2003
Last Updated: December 17, 2013
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:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Levoleucovorin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on October 19, 2014