Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
44
Countries
1
Sites
11
RElapse in previously irradiated Prostate bed
Key facts
- Sponsor
- Institut De Cancerologie De L Ouest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Nov 2020 → ongoing
- Decision date (initial)
- 2024-04-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502642-27-00
- EudraCT number
- 2020-001685-11
- ClinicalTrials.gov
- NCT04536805
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
RElapse in previously irradiated Prostate bed
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Cancerologie De L Ouest
- Sponsor organisation
- Institut De Cancerologie De L Ouest
- Address
- Boulevard Jacques Monod
- City
- Saint Herblain
- Postcode
- 44805
- Country
- France
Scientific contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Stéphane SUPIOT
Public contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Lucie LABARRE
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 44 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Radiotherapy, Bd Du Professeur Jacques Monod, 44800, St Herblain
Clinique Victor Hugo
Radiotherapy, 18 Rue Victor Hugo, Cs 81514, Le Mans Cedex 2
Centre Hospitalier Regional Et Universitaire De Brest
Radiotherapy, 2 Avenue Marechal Foch, 29200, Brest
Centre Leon Berard
Radiotherapy, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Regional Universitaire De Tours
Radiotherapy, 2 Boulevard Tonnelle, 37000, Tours
Institut De Cancerologie De L Ouest
Radiotherapy, 15 Rue Andre Boquel, 49100, Angers
Centr Georges Francois Leclerc
Radiotherapy, 1 Rue Professeur Marion, 21000, Dijon
Centre Oscar Lambret
Radiotherapy, 3 Rue Frederic Combemale, 59000, Lille
Pole Sante Leonard De Vinci
Radiotherapy, 1 Avenue Du Professeur Alexandre Minkowski, 37170, Chambray Les Tours
Centre Henri Becquerel
Radiotherapy, 1 Rue D Amiens, 76000, Rouen
Centre Regional Lutte Contre Le Cancer
Radiotherapy, Batiment Icans, 17 Rue Albert Calmette, Strasbourg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2020-11-26 | 2020-11-26 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-23 | France | Acceptable 2024-04-05
|
2024-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-13 | France | Acceptable 2025-10-24
|
2025-10-27 |