Status:
COMPLETED
Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Erasmus Medical Center
Dutch Cancer Society
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. There are retrospective and preliminary prospect...
Detailed Description
Patients were stratified by hospital, treatment group, age and (neo)adjuvant hormonal therapy. Four treatment groups with specific radiation volumes were defined depending on the estimated risk of tum...
Eligibility Criteria
Inclusion
- locally confined adenocarcinoma of the prostate
- all T-stages with a PSA \< 60ng/ml, except any T1a tumor and well-differentiated (or Gleason score \< 5) T1b-c tumors with PSA-levels ≤ 4 ng/ml
- Karnofsky Performance Status of 80 or more
Exclusion
- distant metastases
- positive regional lymph nodes proven by surgical or cytological sampling
- on anticoagulants
- previous prostatectomy
- previous pelvic irradiation
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
669 Patients enrolled
Trial Details
Trial ID
NCT00692107
Start Date
June 1 1997
End Date
December 1 2007
Last Update
June 6 2008
Active Locations (4)
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1
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
2
Zeeuws Radiotherapeutic Institute
Flushing, Netherlands, 4382 EE
3
Radiotherapeutic Institute Friesland
Leeuwarden, Netherlands, 8934 AD
4
Daniel Den Hoed Cancer Center
Rotterdam, Netherlands, 3075 EA