Status:
COMPLETED
Shorter Radiation Schedule for the Treatment of Prostate Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
NCIC Clinical Trials Group
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
To improve the management of patients with early stage prostate cancer.
Detailed Description
To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men rece...
Eligibility Criteria
Inclusion
- histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
- stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification
Exclusion
- PSA \> 40 mcg/L
- previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
- prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
- simulated volume exceeds 1000 cm3
- previous pelvic radiotherapy
- inflammatory bowel disease
- serious non-malignant disease which would preclude radiotherapy or surgical biopsy
- geographic inaccessibility for follow-up
- psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
- unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
- failure to give informed consent to participate in the study
Key Trial Info
Start Date :
March 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
936 Patients enrolled
Trial Details
Trial ID
NCT00201916
Start Date
March 1 1995
End Date
December 1 2009
Last Update
August 17 2010
Active Locations (16)
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1
B.C. Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
2
B. C. Cancer Agency - Vancouver Cancer Clinic
Vancouver, British Columbia, Canada, V5Z 4E6
3
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
4
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3