Clinical Trial Details
EORTC-1401-BCG
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Management of low grade ductal carcinoma in situ (low-grade DCIS): a randomized, multicenter, non-inferiority trial, between standard therapy approach versus active surveillance
| Trial Status | All trial activities ended |
|---|---|
| Dates |
Date of activation: 30-Jan-2017 Date Step1 close: 15-Jul-2018 |
| Data management at EORTC | Yes |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | All Groups: 1240 |
| Treatment |
Radiotherapy, Drug |
| Study Staff |
Jelle Wesseling (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam Melanie Beauvois (Clinical Operations Manager) , EORTC Headquarters, Brussels Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels Coralie Poncet (Statistician) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels |
| Type of cancer | Breast |
| Participating groups |
EORTC Breast Cancer Group Borstkanker Onderzoek Group Nederland The Netherland Cancer Institute |
| Recruiting centers |
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) ZNA Jan Palfijn (Merksem, Belgium) ZNA Middelheim (Antwerpen, Belgium) |
| Centers to be activated |
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) Hopital Universitaires Erasme (Brussels, Belgium) |
| Protocol summary | http://clinicaltrials.gov/study/NCT02492607 |
| NCT number | NCT02492607 |
| Financial Support | External Grant |
