Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

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. Identifier: NCT00416507
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : May 30, 2016
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for pancreatic cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: liposomal cisplatin Phase 3

Detailed Description:



  • Compare the overall survival of patients with nonresectable, nonmetastatic adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without fluorouracil, cisplatin, and radiotherapy followed by gemcitabine hydrochloride.


  • Compare the toxicities of these regimens in these patients.
  • Compare the objective response (complete, partial, or stable) in patients treated with these regimens.
  • Compare the clinical benefit, in terms of general condition and weight maintenance in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 or 1 vs 2), initial treatment (laparotomy with or without bilio-digestive diversion) (yes vs no), and peritoneal cytology (positive vs negative). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV over 15 minutes on days 1-5 and 29-33 and fluorouracil IV continuously on days 1-40. Patients also undergo radiotherapy daily, 5 days a week, for 6 weeks.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 15 minutes on day 1. Treatment repeats every 7 days for 7 weeks.

Beginning in week 11 of arm I or week 9 of arm II, patients receive gemcitabine hydrochloride IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 190 patients will be accrued for this trial.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables. Randomised Phase III: Initial Radiochimiotherapy (5-FU, Cisplatine, 60 GY Radiotherapy) Followed by Gemcitabine Versus Gemcitabine Alone
Study Start Date : March 2000
Actual Primary Completion Date : July 2005
Actual Study Completion Date : January 2007

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • No neuroendocrine or other histologies
  • No extra-abdominal metastases
  • No hepatic or peritoneal metastases by celioscopy

    • Peritoneal carcinomatous (cytology positive by peritoneal lavage) may be allowed
  • Nonresectable disease meeting ≥ 1 of the following criteria:

    • Arterial invasion
    • Mesenteric-portal vein invasion > 15 mm and or less than hemicircumference
    • Satellite adenopathies encompassed in the radiation field


  • WHO performance status 0-2
  • Bilirubin < 1.75 mg/dL
  • Creatinine < 1.5 mg/dL
  • WBC > 1,500/mm³
  • Platelet count > 100,000/mm³
  • No major organ disorder, including cardiac or coronary insufficiency
  • Prothrombin time > 80%
  • No psychiatric or social condition that would preclude study therapy
  • No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No contraindications to radiotherapy or chemotherapy
  • No intractable pancreatic pain not relieved by morphine and/or analgesic radiotherapy


  • No prior adjuvant or palliative chemotherapy or radiotherapy
  • Prior surgical diversion of the biliary and/or digestive tract allowed

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 identifier (NCT number): NCT00416507

Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Study Chair: Francoise Mornex, MD, PhD Centre Hospitalier Lyon Sud

Publications of Results:
Mornex F, Chauffert B, Bonnetain F, et al.: Definitive results of the French FFCD-SFRO 2000-01 study: phase III trial comparing chemoradiotherapy (cisplatin and infusional 5-FU) followed by gemcitabine vs. gemcitabine alone in patients with locally advanced non metastatic pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 69 (3): A-135, S77, 2007.

Responsible Party: Federation Francophone de Cancerologie Digestive Identifier: NCT00416507     History of Changes
Other Study ID Numbers: CDR0000453847
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the pancreas
stage III pancreatic cancer
stage II pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs