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Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate (NCT00003607)

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.
  • Radiation: radiation therapy
    Ages eligible for Study
    up to 75 Years
    Genders eligible for Study
    Male
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis.

    - Compare the toxic effects of these two regimens in these patients.

    - Compare the quality of life of patients treated with these regimens.

    - Determine the prognostic factors of progression in these patients.

    - Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients.

    OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis).

    Patients are randomized to one of two treatment arms.

    - Arm I: Patients receive pelvic irradiation plus local prostate irradiation.

    - Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks.

    Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter.

    Patients are followed at 2 and 6 months and then every 6 months thereafter.

    PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

    23 locations

    France (23)
    • Centre Paul Papin
      Not specified
      Angers, France, 49036
    • Centre Hospitalier d'Annecy
      Not specified
      Annecy, France, 74011 Cedex
    • Institut Bergonie
      Not specified
      Bordeaux, France, 33076
    • Centre Regional Francois Baclesse
      Not specified
      Caen, France, 14076
    • Centre de Radiotherapie du Parc
      Not specified
      Chalon Sur Saone, France, 71100
    • Centre Hospitalier Universitaire Henri Mondor
      Not specified
      Creteil, France, 94010
    • Centre Oscar Lambret
      Not specified
      Lille, France, 59020
    • Centre Hospital Regional Universitaire de Limoges
      Not specified
      Limoges, France, 87042
    • Clinique de la Sauvegarde - Clinique Jeanne D'Arc
      Not specified
      Lyon, France, 69008
    • Clinique de la Sauvegarde
      Not specified
      Lyon, France, 69008
    • Centre Leon Berard
      Not specified
      Lyon, France, 69373
    • Institut J. Paoli and I. Calmettes
      Not specified
      Marseille, France, 13273
    • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      Not specified
      Montpellier, France, 34298
    • CHR D'Orleans - Hopital de la Source
      Not specified
      Orleans, France, 45067
    • Hopital d'Instruction des Armees du Val de Grace
      Not specified
      Paris, France
    • Centre Hospitalier Lyon Sud
      Not specified
      Pierre Benite, France, 69495
    • Institut Jean Godinot
      Not specified
      Reims, France, 51056
    • Centre Eugene Marquis
      Not specified
      Rennes, France, 35064
    • CHG Roanne
      Not specified
      Roanne, France, F-42300
    • Clinique de l'Orangerie
      Not specified
      Strasbourg, France, 67010
    • Centre Paul Strauss
      Not specified
      Strasbourg, France, 67085
    • Institut Claudius Regaud
      Not specified
      Toulouse, France, 31052
    • Centre Marie Curie
      Not specified
      Valance, France, 26000
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    30 November, 1997
    Updated:
    21 June, 2016
    Participants:
    450
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