Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
Recruitment status was Recruiting
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.
Drug: goserelin acetate
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer|
- Progression-free (biological and/or clinical) survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Metastases-free survival [ Designated as safety issue: No ]
- Immediate and delayed toxicities [ Designated as safety issue: Yes ]
- Delay in reaching the prostate-specific antigen nadir [ Designated as safety issue: No ]
- Quality of life at 1 and 5 years after radiotherapy [ Designated as safety issue: No ]
- Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
- Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer.
- Compare overall survival of patients treated with these regimens.
- Compare metastases-free survival of patients treated with these regimens.
- Compare the immediate and delayed toxicities of these regimens.
- Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.
- Compare the quality of life at 1 and 5 years after radiotherapy in these patients.
- Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
- Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later.
Quality of life is assessed periodically.
After completion of study therapy, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423475
|Centre Paul Papin||Recruiting|
|Angers, France, 49036|
|Contact: Pierre Pabot du Chatelard 33-2-4135-2700|
|Institut Sainte Catherine||Recruiting|
|Avignon, France, 84082|
|Contact: Bruno Chauvet, MD 33-4-9027-6182|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz||Recruiting|
|Besancon, France, 25030|
|Contact: Jean-Francois Bosset, MD 33-381-668310 email@example.com|
|Bordeaux, France, 33076|
|Contact: Pierre Richaud, MD 33-5-56-33-33-20 firstname.lastname@example.org|
|Centre Regional Francois Baclesse||Recruiting|
|Caen, France, 14076|
|Contact: Francois Lesaunier, MD 33-231-455-050 email@example.com|
|Hopital Louis Pasteur||Recruiting|
|Colmar, France, 68024|
|Contact: Nasreddine Feham, MD 33-3-8912-4225|
|Centre Hospitalier Universitaire Henri Mondor||Recruiting|
|Creteil, France, 94000|
|Contact: Jean-Leon Lagrange, MD 33-1-49-814-524 firstname.lastname@example.org|
|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|
|Polyclinique des Quatre Pavillons||Recruiting|
|Lormont, France, 33310|
|Contact: Pierre Guichard, MD 33-5-5780-8489|
|Centre Leon Berard||Recruiting|
|Lyon, France, 69373|
|Contact: Christian Carrie, MD 33-4-78-78-26-45 firstname.lastname@example.org|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes||Recruiting|
|Marseille, France, 13273|
|Contact: Naji Salem, MD 33-4-9122-3637|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: Jean-Bernard Dubois, MD 33-4-6761-3100|
|Neuilly sur Seine, France, 92200|
|Contact: Jean-Michel Vannetzel, MD 33-1-4759-0000|
|Centre Antoine Lacassagne||Recruiting|
|Nice, France, 06088|
|Contact: J. M. Hannoun-Levi, MD 33-49-203-1000|
|Paris, France, 75970|
|Contact: E Touboul, MD 33-56-01-70-00 ext 6210 email@example.com|
|Paris, France, 75475|
|Contact: Christophe Hennequin, PhD 33-1-4249-4949 firstname.lastname@example.org|
|Hopital Europeen Georges Pompidou||Recruiting|
|Paris, France, 75015|
|Contact: Martin Y. Housset, MD 33-1-56-093-401 email@example.com|
|Hopital Saint Joseph||Recruiting|
|Paris, France, 75674|
|Contact: Gael Deplanque, MD, MSC, PhD 33-1-4412-7626 firstname.lastname@example.org|
|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre Benite, France, 69495|
|Contact: Pascale Romestaing, MD 33-4-78-86-42-51 email@example.com|
|Poitiers, France, 86021|
|Contact: Stephane Guerif 33-5-4944-4485|
|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|
|Roanne, France, F-42300|
|Contact: Jean Philippe Suchaud 33-4-7744-3396|
|Clinique Armoricaine De Radiologie||Recruiting|
|Saint Brieuc, France, F-22015|
|Contact: Ali Hasbini, MD 33-2-9675-2220 firstname.lastname@example.org|
|Centre Rene Huguenin||Recruiting|
|Saint Cloud, France, 92211|
|Contact: P. Moisson, MD 33-1-47-111-515|
|Saint Etienne, France, 42013|
|Contact: Nicolas Mottet, MD, PhD 33-477-12-11-47 email@example.com|
|Institut de Cancerologie de la Loire||Recruiting|
|Saint Priest en Jarez, France, 42270|
|Contact: Guy De Laroche, MD 33-4-7791-7102|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Jean-Marc Bachaud, MD 33-5-6142-4242|
|Centre Marie Curie||Recruiting|
|Valence, France, 26000|
|Contact: Sebastien Clippe, MD 33-47-581-3381 firstname.lastname@example.org|
|Centre Alexis Vautrin||Recruiting|
|Vandoeuvre-les-Nancy, France, 54511|
|Contact: Veronique Beckendorf 33-3-8359-8425|
|Study Chair:||Christian Carrie, MD||Centre Leon Berard|