Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
European Study Group For Pancreatic Cancer - Trial 3
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.


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.


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 Started
Jul 31
Primary Completion
Apr 30
Study Completion
Sep 30
Last Update
Dec 18

Drug fluorouracil

Given IV

Drug gemcitabine hydrochloride

Given IV

Drug leucovorin calcium

Given IV

Other clinical observation

No intervention

Arm I Active Comparator

Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.

Arm II Experimental

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.

Arm III No Intervention

Patients undergo observation.



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



18 and over

Performance status

WHO 0-2

Life expectancy

More than 3 months


Not specified


Not specified


Not specified


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


Biologic therapy

Not specified


No neoadjuvant chemotherapy
No other concurrent chemotherapy

Endocrine therapy

Not specified


Not specified


See Disease Characteristics
Recovered from prior resection
No Results Posted