Conformational, Curative Ratiotherapy For Prostate Cancer (NO, N-): Phase III Multicenter Study Of The Contribution To Survival Without Clinical Or Biological Change With A Dose Variation Of 15% (80 Gy VS 70 Gy)
N/A
74 Years
Male
Prostate Cancer
Trial Information
Conformational, Curative Ratiotherapy For Prostate Cancer (NO, N-): Phase III Multicenter Study Of The Contribution To Survival Without Clinical Or Biological Change With A Dose Variation Of 15% (80 Gy VS 70 Gy)
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.
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 306 patients (153 per arm) will be accrued for this study
within 2.5 years.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
P. Bey, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Alexis Vautrin
Authority:
United States: Federal Government
Study ID:
CDR0000068458
NCT ID:
NCT00010244
Start Date:
September 1999
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
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