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.
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