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

NCT03266900 | Terminated Early Phase 1 DMC

• 1 other identifier: 17-5305.0
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Bladder Cancer; Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 5 year Progression Free Survival

  5 years

Secondary Outcomes (4)

• Clinical Measures - These include recurrence free survival (in the bladder), time to cystectomy, and metastases-free survival as measured over time from intervention to 5-years post-intervention.

  5 years

• Survival Measures - These include disease specific survival and overall survival as measured over time from intervention to 5-years post-intervention.

  5 years

• Perioperative Safety Measures - These include rate of major complications as defined by the Clavien-Dindo classification as grade 3, 4, and 5.

  5 years

• Mean Change of Patient FACT BI Scores - This includes prospective collection with a validated BCa HRQOL instruments performed at each patient visit.

  5 years

Study Arms (2)

re-TURBT

EXPERIMENTAL

Patients in this arm will receive a 2nd TURBT within 4-6 weeks of initial TURBT

Procedure: re-TURBT

6 BCG instillations

ACTIVE COMPARATOR

Patients in this arm will not receive a 2nd TURBT, but will receive 6 instillations of BCG.

Drug: 6 weeks BCG instillation

Interventions

re-TURBT PROCEDURE

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

re-TURBT

6 weeks BCG instillation DRUG

standard 6 weeks of BCG induction

6 BCG instillations

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete initial resection by a BCa-focused urologic oncologist; mandatory bladder detrusor muscle in the initial TURBT specimen and complete visible resection documented by the surgeon/OR staff by intra-operative photography.
• Urothelial carcinoma as the predominant histology as determined by genitourinary specific pathologist (e.g. small (\<50%) components of small cell, squamous cell or adenocarcinoma are allowable).
• Able and willing to consent.
• ≥18 years old: BCa is primarily a disease of the elderly, thus we have elected to include healthy octogenarian/nonagenarian patients. Additionally, since a TURBT can be performed under general or spinal anesthesia, we feel that including these patients is acceptable.

You may not qualify if:

• Lymph node or distant metastases at initial presentation - determined on standard BCa staging evaluation with a CT-urogram of the abdomen/pelvis and/or a preoperative chest x-ray demonstrating pulmonary metastases.
• Extensive NMIBC disease warranting immediate cystectomy.
• Variant histology (not urothelial carcinoma) - ie. micropapillary, plasmacytoid, nested or sarcomatoid variants.
• No muscularis propria (inadequate bladder staging) present in the initial TURBT specimen.
• Initial TURBT demonstrating T1HG disease performed outside of study centre - as per study protocol, quality control of surgical performance for this trial requires the TURBT to be performed by an experienced BCa-dedicated surgeon.
• Patients with severe comorbidities, including but not limited to: (i) previous stroke with persistent cognitive, motor, etc deficits; (ii) recent (\<6 months) myocardial infarction or current unstable angina; (iii) liver cirrhosis; (iv) severe chronic obstructive pulmonary disease (COPD)/respiratory disease. Patients must be suitable candidates for either spinal or general anesthesia.
• Pregnancy or lactation.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Bladder Cancer Canada: collaborator
• Canadian Urological Association: collaborator
• Canadian Urologic Oncology Group: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Girish Kulkarni, MD PhD FRCSC

  University Health Network - Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 30, 2017
• Study Start: November 16, 2017
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)