Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic 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: NCT00112697
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2005
Last Update Posted : November 2, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, 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. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: cisplatin Drug: docetaxel Drug: fluorouracil Radiation: radiation therapy Phase 2

Detailed Description:



  • Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy.


  • Compare the toxicity of these regimens in these patients.
  • Compare the objective response rate in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.
  • Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks.

In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Study Start Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival rate at 6 months

Secondary Outcome Measures :
  1. Toxicity
  2. Objective response rate
  3. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • No other pancreatic tumor type, including either of the following:

      • Neuroendocrine tumor
      • Ampulla of Vater carcinoma
    • Metastatic disease
  • Measurable or evaluable disease
  • Unresectable disease, defined as either of the following:

    • Failed prior attempt of surgical resection by laparotomy
    • Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)
  • No cerebral metastases



  • 18 to 75

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin < 1.5 times upper limit of normal
  • No hepatic disturbance


  • Creatinine < 120 mmol/L


  • No untreated cardiac or coronary insufficiency
  • No uncontrolled symptomatic arrhythmia
  • No uncontrolled angina


  • No uncontrolled respiratory insufficiency


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy ≥ grade 2
  • No ongoing active infection
  • No other serious uncontrolled medical disorder that would preclude study treatment


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the celiac or pancreatic area


  • See Disease Characteristics

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): NCT00112697

Centre Paul Papin
Angers, France, 49036
Centre Oscar Lambret
Lille, France, 59020
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Study Chair: Michel Ducreux, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris

Publications of Results: Identifier: NCT00112697     History of Changes
Other Study ID Numbers: CDR0000430095
First Posted: June 3, 2005    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: December 2006

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage IV 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
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs