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

April 7, 2003
December 17, 2013
July 2001
April 2008   (final data collection date for primary outcome measure)
Overall survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00058201 on ClinicalTrials.gov Archive Site
  • 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 ]
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Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
European Study Group For Pancreatic Cancer - Trial 3

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: fluorouracil
    Given IV
  • Drug: gemcitabine hydrochloride
    Given IV
  • Drug: leucovorin calcium
    Given IV
  • Other: clinical observation
    No intervention
  • Active Comparator: Arm I
    Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
    Interventions:
    • Drug: fluorouracil
    • Drug: leucovorin calcium
  • Experimental: Arm II
    Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
    Intervention: Drug: gemcitabine hydrochloride
  • No Intervention: Arm III
    Patients undergo observation.
    Intervention: Other: clinical observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1030
September 2010
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Sweden,   Switzerland,   United Kingdom
 
NCT00058201
CDR0000287023, RLUH-NCRI-ESPAC-3V2, EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3
Not Provided
Not Provided
Royal Liverpool University Hospital
  • NCIC Clinical Trials Group
  • Australasian Gastro-Intestinal Trials Group
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
National Cancer Institute (NCI)
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP