Study

EORTC-2335-GUCG

Radiotherapy for BCG-unresponsive non-muscle-invasive Carcinoma in Situ (CIS) bladder cancer: an open-label, single-arm, multicenter, phase 2 study

Trial Status

Recruiting

Dates

Date of activation: 23-Jul-2026

Data management at EORTC

Yes

Design

Phase 2
Not randomized / N.A.

Targeted Sample size

EORTC Groups: 50 - All Groups: 50

Treatment

Radiotherapy

Study Staff

  • Piet Dirix (Study Coordinator), ZAS Augustinus (previous GZA), Wilrijk
  • Verane Achard (Y-ECI Coordinator), Institut Bergonie, Bordeaux
  • Hanne Locy (Project Manager), EORTC Headquarters, Brussels
  • Bert Dhondt (Clinical Research Physician), EORTC Headquarters, Brussels
  • Beatrice Fournier (Medical representative), EORTC Headquarters, Brussels
  • Luc Boone (Statistician), EORTC Headquarters, Brussels
  • Corneel Coens (Statistician), EORTC Headquarters, Brussels
  • Jammbe Musoro (Statistician), EORTC Headquarters, Brussels
  • Ellen Peeters (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Florence Dujardin (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Bart Meulemans (Data Manager), EORTC Headquarters, Brussels
  • Nabila Sebti (Data Manager), EORTC Headquarters, Brussels
  • Bart Meulemans (Clinical Data Expert), EORTC Headquarters, Brussels
  • Anna Fleming (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Laurens Vinckier (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Lore Hermans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Eliza Starczewska (Regulatory Affairs Manager), EORTC Headquarters, Brussels
  • Salvatore Mazza (Lead CRA), EORTC Headquarters, Brussels
  • Youness Benyahya (Clinical Operations Assistant), EORTC Headquarters, Brussels
  • Luiza Souza (RTQA Officer), EORTC Headquarters, Brussels

Type of cancer

  • Bladder

Participating groups

  • EORTC Genito-Urinary Cancers Group

Recruiting centers

  • ZAS Augustinus (previous GZA) (Wilrijk, Belgium)

Centers to be activated

  • APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France)
  • CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
  • CLCC - Jean Perrin (CLERMONT FERRAND , France)
  • Centre Oscar Lambret (LILLE CEDEX, France)
  • Cliniques Universitaires Saint-Luc (Brussels, Belgium)
  • Gustave Roussy (VILLEJUIF CEDEX, France)
  • Institut Bergonie (Bordeaux, France)
  • Institut Jules Bordet (Anderlecht, Belgium)
  • Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France)
  • Jessa Ziekenhuis - Campus Virga Jesse (Hasselt, Belgium)
  • UPMC Hillman Cancer Center-Croatia (Zabok, Croatia)
  • Universitair Ziekenhuis Gent (Gent, Belgium)
  • Ziekenhuis Oost Limburg (Genk, Belgium)

Protocol summary

NCT number

NCT06990061