Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer
This study has been completed.
Sponsor:
Laboratoires Takeda
Information provided by:
Laboratoires Takeda
ClinicalTrials.gov Identifier:
NCT01122121
First received: May 7, 2010
Last updated: May 10, 2010
Last verified: May 2010
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Purpose
the purpose of this study "Leuprorelin associated with radiotherapy versus leuprorelin alone in T3 - T4 or pT3 (on biopsy) N0, M0 prostate cancer" is to assess the possible benefits of the combined treatment on the local or systemic recurrences and on quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
Histologically Confirmed Locally Advanced Prostatic Cancer no Previous Treatment for the Prostate Cancer |
Drug: Leuprorelin 11,25 mg SR Drug: Radiotherapy + hormonotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacité et tolérance comparées de la Combinaison radiothérapie-hormonothérapie Adjuvante et de l'hormonothérapie Seule Dans Les Cancers de la Prostate Localement évolués (T3-T4 ou pT3 Biopsiques,N0, M0) |
Resource links provided by NLM:
Further study details as provided by Laboratoires Takeda:
Primary Outcome Measures:
- 5 year progression free survival [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to biological progression [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]
- Time to clinical progression [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]
| Enrollment: | 273 |
| Study Start Date: | March 2000 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Radiotherapy + hormonotherapy
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years) + radiotherapy 70 +/- 4 Grays(RT begun within 90 days after 1st leuprorelin injection)
|
Drug: Radiotherapy + hormonotherapy
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years) + radiotherapy 70 +/- 4 Grays(RT begun within 90 days after 1st leuprorelin injection)
|
|
Hormonotherapy alone
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years) alone
|
Drug: Leuprorelin 11,25 mg SR
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years)
|
Detailed Description:
STUDY DESIGN :
French multicenter, open, randomized study on 2 parallel groups
First step : treatment during 3 years (excepted disease progression) with Leuprorelin 11,25 mg SR + radiotherapy 70 +/- 4 Grays(begun within 90 days after 1st leuprorelin injection) in the first arm and Leuprorelin 11,25 mg SR alone for the 2nd arm. A visit / 6 months.
Second step : follow-up without treatment during 2 years (excepted disease progression). A visit / 6 months.
Third step : Follow-up out of protocol. 1 data collection / year.
End of study when median follow-up = 5years.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed locally advanced prostatic cancer : T3 or T4 or pT3 (on biopsy), N0, M0
- Patient whose prostatic cancer has never been treated (excepted transurethral resection for obstructive syndrom)
- Karnofsky > or = 70
- Age < 80 years old
- Life expectancy > 7 years
- Informed consent given by the patient
- No abnormal transaminases (> or = 3* normal values) on a recent sample (< 2 months)
Exclusion Criteria:
- Patient who could not understand the information regarding the study and give his informed written consent, or patient who has refused to sign the informed consent sheet,
- Patient who could not respect the conditions of the protocol,
- Patient who has already received a previous treatment for his prostate cancer, excepted transurethral resection for obstructive syndrom,
- Patient who has been surgically castrated or with a medical history of bilateral suprarenalectomy or hypophysectomy,
- Patient who had another cancer during the 5 last years excepted a basal cell carcinoma or a carcinoma in situ (excepted bladder),
- Patient with a ganglionic or metastatic prostate cancer extension suspected on exams,
- Patient with a serious and unstable pathology,
- Patient who could not receive a prostatic external irradiation,
- Patient receiving or who has received another experimental treatment during the 3 last months,
- Patient with a hepatic insufficiency or abnormal transaminases (> or = 3* normal values).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122121
Locations
| France | |
| Clinique Mutualiste | |
| Saint-etienne, France, 42013 | |
Sponsors and Collaborators
Laboratoires Takeda
Investigators
| Principal Investigator: | Nicolas MOTTET, Dr | Clinique Mutualiste - Saint-Etienne |
| Principal Investigator: | Pierre RICHAUD, Dr | Institut BERGONIÉ, Centre Régional de Lutte contre le Cancer, Bordeaux |
| Principal Investigator: | Michel PENEAU, Dr | Martinique |
| Principal Investigator: | Jean-Jacques MAZERON, Pr | Groupe Hospitalier PITIE-SALPETRIERE, Paris |
More Information
No publications provided
| Responsible Party: | Dcoteur Mehemed OUZID, Responsable des Opérations Cliniques, Laboratoires TAKEDA |
| ClinicalTrials.gov Identifier: | NCT01122121 History of Changes |
| Other Study ID Numbers: | TAP III/98/032 |
| Study First Received: | May 7, 2010 |
| Last Updated: | May 10, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Laboratoires Takeda:
|
locally advanced prostatic cancer radiotherapy + hormonotherapy versus hormonotherapy alone |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Leuprolide |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013