Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
|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.|
|ClinicalTrials.gov Identifier: NCT00104741|
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 4, 2005
Last Update Posted : February 21, 2011
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: flutamide Drug: triptorelin Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Official Title:||Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis|
|Study Start Date :||July 2004|
- Impact of complete androgen blockade for 4 months
- Survival, in terms of clinical or biological remission, at 5 years
- Overall survival
- Acute and late toxicity
- Quality of life
- Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)
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 ClinicalTrials.gov identifier (NCT number): NCT00104741
|Clinique De Rochebelle||Recruiting|
|Ales, France, F-30100|
|Contact: Jacques Cretin 33-4-6654-2110|
|Institut Sainte Catherine||Recruiting|
|Avignon, France, 84082|
|Contact: Bruno Chauvet, MD 33-4-9027-6182|
|Hopital Louis Pasteur||Recruiting|
|Colmar, France, 68024|
|Contact: Contact Person 33-03-89-12-4102|
|Hopitaux Civils de Colmar||Recruiting|
|Colmar, France, 68024|
|Contact: Contact Person 33-3-8912-4000|
|Centre Hospitalier Universitaire Henri Mondor||Recruiting|
|Creteil, France, 94000|
|Contact: Jean-Leon Lagrange, MD 33-1-49-814-524 email@example.com|
|Hopital Intercommunal De Creteil||Recruiting|
|Creteil, France, 94010|
|Contact: Michel Martin, MD 33-1-45-17-52-10 firstname.lastname@example.org|
|Hopital Jean Monnet||Recruiting|
|Epinal, France, 88021|
|Contact: Michel Aubertel 33-3-2968-7020|
|Centre Hospitalier Intercommunal des Alpes du Sud||Recruiting|
|Gap, France, 05007|
|Contact: Abdellatif Zribi, MD 33-4-9240-6785|
|Centre Oscar Lambret||Recruiting|
|Lille, France, 59020|
|Contact: Eric Lartigau, MD, PhD 33-3-2029-5911 email@example.com|
|Centre Hospital Regional Universitaire de Limoges||Recruiting|
|Limoges, France, 87042|
|Contact: Pierre Clavere, MD 33-5-5505-6268 firstname.lastname@example.org|
|Centre Leon Berard||Recruiting|
|Lyon, France, 69373|
|Contact: Pascal Pommier, MD 33-4-7878-2648 email@example.com|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes||Recruiting|
|Marseille, France, 13273|
|Contact: Contact Person 33-91-22-37-00|
|CHU de la Timone||Recruiting|
|Marseille, France, 13385|
|Contact: Contact person 33-91-385-708|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: Jean-Bernard Dubois, MD 33-4-6761-3100|
|Centre Hospitalier de Mulhouse||Recruiting|
|Mulhouse, France, 68051|
|Contact: Contact Person 33-3-8964-7522|
|Mulhouse, France, 68070|
|Contact: Alain Grandgirard 33-3-8964-7522|
|Centre Regional Rene Gauducheau||Recruiting|
|Nantes, France, 44035|
|Contact: Sylvain Bourdin, MD 33-2-4067-9900|
|Centre Antoine Lacassagne||Recruiting|
|Nice, France, 06088|
|Contact: J. M. Hannoun-Levi, MD 33-4-9203-1260|
|Clinique De Valdegour||Recruiting|
|Nimes, France, 30900|
|Contact: Jacques Cretin, MD 33-46-662-58-02|
|Hopital d'Instruction des Armees du Val de Grace||Recruiting|
|Paris, France, 75005|
|Contact: Maryse Fayolle-Campana 33-1-4051-4558|
|Paris, France, 75475|
|Contact: Christophe Hennequin, PhD 33-1-4249-4949 firstname.lastname@example.org|
|Paris, France, 75651|
|Contact: Jean-Marc Simon 33-142-178-174|
|Paris, France, 75970|
|Contact: Francoise Pene, MD 33-1-5601-6562 email@example.com|
|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre Benite, France, 69495|
|Contact: Contact Person 33-4-78-86-11-58|
|Poitiers, France, 86021|
|Contact: Contact Person 33-549-444-538|
|Institut Jean Godinot||Recruiting|
|Reims, France, 51056|
|Contact: Tan Dat Nguyen, MD 33-03-2650-4351 firstname.lastname@example.org|
|Centre Eugene Marquis||Recruiting|
|Rennes, France, 35064|
|Contact: Elizabeth Le Prise, MD 33-2-9925-3000 email@example.com|
|Centre Henri Becquerel||Recruiting|
|Rouen, France, 76000|
|Contact: Bernard M. Dubray, MD, PhD 33-232-082-262|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Jean-Marc Bachaud, MD 33-5-6142-4242|
|Centre Hospitalier Universitaire Bretonneau de Tours||Recruiting|
|Tours, France, 37044|
|Contact: Olivier Le Floch, MD 33-2-4747-4776 firstname.lastname@example.org|
|Centre Alexis Vautrin||Recruiting|
|Vandoeuvre-les-Nancy, France, 54511|
|Contact: Contact Person 33-3-8359-8400|
|Study Chair:||Bernard M. Dubray, MD, PhD||Centre Henri Becquerel|