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Clinical Trials/CTRI/2021/10/037060
CTRI/2021/10/037060Recruiting未知

EARLY TOXICITIES AND CLINICAL OUTCOMES OF EXTENDED FIELD RADIATION THERAPY WITH VOLUMETRIC MODULATED ARC THERAPY IN PROSTATE CANCER

PGIMER0 sites0 target enrollmentStarted: TBDLast updated:

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

Sponsor
PGIMER

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