Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
70
Countries
1
Sites
5
Rectal adenocarcinoma
Key facts
- Sponsor
- Institut De Cancerologie De L Ouest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Apr 2019 → 12 Feb 2026
- Decision date (initial)
- 2024-06-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512855-19-00
- EudraCT number
- 2018-002079-17
- ClinicalTrials.gov
- NCT03951337
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rectal adenocarcinoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Cancerologie De L Ouest
- Sponsor organisation
- Institut De Cancerologie De L Ouest
- Address
- Bd Du Professeur Jacques Monod
- City
- St Herblain
- Postcode
- 44800
- Country
- France
Scientific contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- HIRET Sandrine
Public contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- ALLAM Nadia
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 70 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Henri Becquerel
Nuclear Medicine, 1 Rue D Amiens, 76000, Rouen
Institut De Cancerologie De L Ouest
Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut De Cancerologie De L Ouest
Nuclear Medicine, 15 Rue Andre Boquel, 49100, Angers
Centre Hospitalier Regional Et Universitaire De Brest
Nuclear Medicine, 2 Avenue Marechal Foch, 29200, Brest
Centre De Lutte Contre Le Cancer Eugene Marquis
Nuclear Medicine, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
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 | 2019-04-30 | 2026-02-12 | 2019-04-30 | 2023-06-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-07 | France | Acceptable 2024-06-12
|
2024-06-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-05 | France | Acceptable 2025-05-23
|
2025-07-07 |