Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer

NCT06310369 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: EORTC 2335-GUCG
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has yet to be fully explored.

Conditions

Bladder Cancer

Keywords

NMIBC

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a complete response at 6 months post-radiotherapy

  6 months post-radiotherapy

Secondary Outcomes (2)

• Progression-free survival

  5 years from randomisation

• overall survival

  5 years from randomisation

Study Arms (1)

Radiotherapy arm

EXPERIMENTAL

Radiation therapy will be given covering the whole bladder over 4 weeks. The use of a radiosensitizing agent is mandatory.

Radiation: radiation therapy

Interventions

radiation therapy RADIATION

Radiation therapy will be given in 20 fractions of 2.75 Gy covering the whole bladder over 4 weeks. The use of a radiosensitizing agent is mandatory. Each recruiting center will have to choose 2 options of radiosensitizing agents.

Radiotherapy arm

Eligibility Criteria

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

You may qualify if:

• years or older with histologically confirmed, BCG-unresponsive, high-risk non-muscle-invasive bladder cancer of predominantly (\>50%) urothelial histology who were ineligible for or declined to undergo radical cystectomy
• Patients with carcinoma in situ with or without high-grade Ta or T1
• Eastern Cooperative Oncology Group performance status of 0-2, and adequate organ function
• Patients with concomitant Ta and T1 tumours must have undergone complete TURBT, defined as per standard of care as a visually complete resection (residual carcinoma in situ, which is traditionally not amenable to complete transurethral resection is acceptable), and the most recent cystoscopy or TURBT must have been done within 12 weeks before study initiation. Presence of detrusor muscle on pathology samples is required to ensure sample adequacy. A second TURBT is recommended but not required for patients with T1 tumours. The use of either white-light cystoscopy or blue-light cystoscopy is permitted, but the same technique has to be used in a patient throughout the trial
• Definition of BCG unresponsive non-muscle-invasive bladder cancer according to the European Association of Urology (EAU) guidelines

You may not qualify if:

• Evidence of upper urinary tract carcinoma
• Hydronephrosis due to tumour in the presence of T1 disease
• Patients on current systemic therapy for bladder cancer
• Patients who have received pelvic external beam radiotherapy within the previous 5 years

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

Radiotherapy

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Verane Achard, Dr

  Fribourg Cantonal Hospital

  STUDY CHAIR

Central Study Contacts

EORTC

CONTACT

+3227741611; eortc@eortc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 22, 2024

Record last verified: 2024-07