CTRI/2021/10/037060Recruiting未知
EARLY TOXICITIES AND CLINICAL OUTCOMES OF EXTENDED FIELD RADIATION THERAPY WITH VOLUMETRIC MODULATED ARC THERAPY IN PROSTATE CANCER
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- PGIMER
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. HISTO-PATHOLOGICALLY PROVEN CASES OF ADENOCARCINOMA PROSTATE.
- •2. PATIENTS FULFILLING EITHER OF THE FOLLOWING CRITERIA:
- •A) CLINICALLY PELVIC LYMPH NODE POSITIVE NON-METASTATIC DISEASE.
- •B) STAGE M1A (PARA-AORTIC NODES/COMMON ILIAC NODAL INVOLVEMENT).
- •C) PATHOLOGICAL NODE POSITIVITY AFTER RADICAL PROSTATECTOMY.
- •D) POST OP CASES WITH RADIOLOGICALLY POSITIVE LYMPH NODES, TO BE PLANNED FOR SALVAGE RADIOTHERAPY.
- •E) HIGH-RISK DISEASE WITH RISK OF LYMPH NODE INVOLVEMENT >15% BY ROACH FORMULA.
- •(2/3 X PROSTATE-SPECIFIC ANTIGEN +(GLEASON SCORE-6) x10).
- •3. PATIENTS WITH GOOD PERFORMANCE STATUS ECOG 0-2.
- •4. PATIENTS WHO GIVE SIGNED INFORMED CONSENT.
Exclusion Criteria
- •1. PROSTATE CANCER PATIENTS WITH ANY OF THE FOLLOWING.
- •A) BONE OR VISCERAL METASTATIC DISEASE.
- •B) POSITIVE NON-REGIONAL LYMPH NODES (CLINICAL/IMAGING/PATHOLOGY) OTHER THAN IN COMMON ILIAC OR PARA-AORTIC REGIONS.
- •C) HISTORY OF PRIOR RADIOTHERAPY TO PELVIS AND/OR PARA-AORTIC REGION.
- •2. PATIENTS WITH POOR PERFORMANCE STATUS ECOG-3/4.
- •3. PATIENTS WITH LIFE EXPECTANCY LESS THAN 2 YEARS.
Investigators
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