Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
NCT ID: NCT00104741
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
378 participants
INTERVENTIONAL
2003-09-10
2015-10-15
Brief Summary
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PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.
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Detailed Description
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* Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer.
* Compare the survival rate, in terms of 5-year clinical or biological remission, in patients treated with these regimens.
* Compare overall survival in patients treated with these regimens.
* Compare acute and late toxicity of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.
* Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo conformal external beam radiotherapy.
* Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a total of 4 months. Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy.
Quality of life is assessed.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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radiotherapy alone
radiation therapy
Radiotherapy + androgene deprivation
flutamide
triptorelin
radiation therapy
Interventions
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flutamide
triptorelin
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate cancer, meeting the following clinical staging criteria:
* Stage T1b-T1c AND prostate specific antigen (PSA) ≥ 10 ng/mL OR Stage T1b-T1c AND Gleason score ≥ 7 OR Stage T2a-T3a
* No lymph node invasion (N0 or N-)
* Patients with ≥ 10% risk by the Partin table must undergo curage
* No metastatic disease (M0) by thoracic radiography and bone scan
* PSA \< 30 ng/mL
* No history of invasive cancer
PATIENT CHARACTERISTICS:
Age
* Under 75
Performance status
* ECOG 0-1
Life expectancy
* At least 10 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* No prior hormonal therapy
Radiotherapy
* No prior pelvic radiotherapy
Surgery
* No prior radical prostatectomy
* No prior castration
0 Years
74 Years
MALE
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Bernard M. Dubray, MD, PhD
Role: STUDY_CHAIR
Centre Henri Becquerel
Locations
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Clinique De Rochebelle
Alès, , France
Institut Sainte Catherine
Avignon, , France
Hopital Louis Pasteur
Colmar, , France
Hopitaux Civils de Colmar
Colmar, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Hopital Intercommunal De Creteil
Créteil, , France
Hopital Jean Monnet
Épinal, , France
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, , France
Centre Oscar Lambret
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Centre Leon Berard
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
CHU de la Timone
Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Centre Hospitalier
Mulhouse, , France
Centre Regional Rene Gauducheau
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Clinique De Valdegour
Nîmes, , France
Hopital d'Instruction des Armees du Val de Grace
Paris, , France
Hopital Saint-Louis
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Tenon
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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References
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Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.
Other Identifiers
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FRE-FNCLCC-GETUG-14/0207
Identifier Type: -
Identifier Source: secondary_id
EU-20503
Identifier Type: -
Identifier Source: secondary_id
UC-0160/0207
Identifier Type: -
Identifier Source: org_study_id
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