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Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer Clinical research trials and Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer. Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer clinical trial. Human subjects often get the best healthcare possible for their Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer  Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer
Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer
For Condition: stage 2 prostate cancer,stage 3 prostate cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer.
Details: OBJECTIVES: I. Compare the 5-year survival rate, in terms of clinical and biological remission, in patients with localized prostate cancer treated with two different radiotherapy regimens using different doses and number of fractions. II. Compare the nadir of PSA and the delay in obtaining the nadir in patients treated with these two regimens. III. Compare acute and long-term toxicity of these two regimens in these patients. IV. Compare overall survival and quality of life in patients treated with these two regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive radiotherapy to the seminal vesicles at 46 Gy in 23 fractions and to the prostate at 70 Gy in 35 fractions, with 5 fractions per week. Arm II: Patients receive radiotherapy to the seminal vesicles as in arm I and to the prostate at 80 Gy in 40 fractions, with 5 fractions per week. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Quality of life is assessed annually. Patients are followed every 4 months for a minimum of 5 years. PROJECTED ACCRUAL: A total of 250 patients (125 per arm) will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /74 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Localized prostate cancer: T2a-T3a OR T1b or T1c with PSA at least 10 ng/mL OR T1b or T1c with Gleason score 7-10 No T3b or T4; positive biopsy of nodal excision N0, or any N with bilateral removal and the estimated risk of nodal invasion is at least 10% M0 (by bone scintograph and chest x-ray) - PSA less than 50 ng/mL --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy; No concurrent biologic therapy - Chemotherapy: No prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: No prior hormonal therapy including adjuvant therapy; No concurrent hormonal therapy - Radiotherapy: No prior pelvic radiotherapy - Surgery: No prior radical anterior prostatectomy for cancer; No prior castration --Patient Characteristics-- - Age: Under 75 - Performance status: WHO 0-1 - Life expectancy: At least 10 years - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: No other prior invasive malignancy within the past 5 years except basal cell carcinoma; No social, familial, or geographic obstacles that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
P.Bey, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Centre Henri Becquerel
Rouen, , 76038
France
Centre Antoine Lacassagne
Nice, , 06189
France
Hopital Saint Andre
Bordeaux, , 33075
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Centre Leon Berard
Lyon, , 69373
France
Institut Claudius Regaud
Toulouse, , 31052
France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , 37044
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Centre Eugene Marquis
Rennes, , 35064
France
Institut Jean Godinot
Reims, , 51056
France
Hopital Jean Bernard
Poitiers, , 86021
France
Institut Curie - Section Medicale
Paris, , 75248
France
Hopital Notre-Dame de Bon Secours
Metz, , 55038
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Hopital Jules Courmont - Centre Hospitalier Lyon Sud
Pierre-Benite, , 69495
France
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
CHU Pitie-Salpetriere
Paris, , 75651
France
Additional Information:
Study ID Numbers: CDR0000068458; FRE-FNCLCC-PAC-GETUG-06-99001,EU-20037
Study Start Date: September 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010244
Other Stage 2 Prostate Cancer Studies:
1. Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer
2. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
3. Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer
4. Bortezomib and Mitoxantrone in Treating Patients With Advanced or Metastatic Androgen-Independent Prostate Cancer
5. Neoadjuvant Thalidomide in Treating Patients With Locally Advanced Prostate Cancer Who Are Undergoing Radical Prostatectomy
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Clinical Trials
Other Toulouse Clinical Trials
Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer
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