A Superiority Trial to Compare Re-resection of High-grade T1 Bladder Urothelial Carcinoma to no Re-resection for Improving Progression Free Survival

NCT03266900 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-04-20

No results posted yet for this study

Summary

The investigators would like to compare the progression free survival, overall survival, quality of life, and safety outcomes of patients receiving versus not receiving a 2nd transurethral resection of bladder tumor.

Conditions

Interventions

PROCEDURE

re-TURBT

2nd bladder biopsy within 4-6 weeks of initial biopsy

DRUG

6 weeks BCG instillation

standard 6 weeks of BCG induction

Sponsors & Collaborators

  • Bladder Cancer Canada

    collaborator UNKNOWN
  • Canadian Urological Association

    collaborator INDUSTRY
  • Canadian Urologic Oncology Group

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Girish Kulkarni, MD PhD FRCSC · University Health Network - Princess Margaret Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2021-10-04
Completion
2021-10-04

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03266900 on ClinicalTrials.gov