Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003607
First received: November 1, 1999
Last updated: February 18, 2011
Last verified: December 2004
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 450
Study Start Date: December 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma of the prostate

    • Stage I (T1b or T1c, N0, M0)
    • Stage II (T2, N0, M0)
    • Stage III (T3, N0, M0)
  • Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria:

    • Gleason score at least 7
    • Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN)
    • T3 OR
  • Good prognosis defined as meeting 1 of the following criteria:

    • T1b or T2
    • T1c with Gleason score less than 7 and PSA less than 3 times ULN
  • No metastases by bone scans or chest x-ray

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 10 years

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other malignancy within the past 10 years except basal cell skin cancer
  • No adenopathies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months
  • No concurrent luteinizing hormone-releasing hormone agonists
  • No concurrent anti-androgen therapy
  • No concurrent hormonal therapy in high-risk group

Radiotherapy:

  • No prior pelvic radiotherapy

Surgery:

  • No prior lymphadenectomy
  • No prior surgical castration
  • No prior prostatectomy
  • At least 1 month since prior transurethral resection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003607

Locations
France
Centre Paul Papin
Angers, France, 49036
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Centre de Radiotherapie du Parc
Chalon Sur Saone, France, 71100
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94010
Centre Oscar Lambret
Lille, France, 59020
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Clinique de la Sauvegarde
Lyon, France, 69008
Centre Leon Berard
Lyon, France, 69373
Clinique de la Sauvegarde - Clinique Jeanne D'Arc
Lyon, France, 69008
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
Hopital d'Instruction des Armees du Val de Grace
Paris, France
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35064
CHG Roanne
Roanne, France, F-42300
Centre Paul Strauss
Strasbourg, France, 67085
Clinique de l'Orangerie
Strasbourg, France, 67010
Institut Claudius Regaud
Toulouse, France, 31052
Centre Marie Curie
Valance, France, 26000
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Pascal Pommier, MD Centre Leon Berard
  More Information

Additional Information:
Publications:
Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.

ClinicalTrials.gov Identifier: NCT00003607     History of Changes
Other Study ID Numbers: CDR0000066684, FRE-FNCLCC-GETUG-01, EU-98029
Study First Received: November 1, 1999
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014