Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
160
Countries
1
Sites
22
Colon cancer
Key facts
- Sponsor
- Institut Regional Du Cancer De Montpellier
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515340-23-00
- EudraCT number
- 2016-002576-27
- ClinicalTrials.gov
- NCT03255434
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Colon cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10009991 | Colonic cancer stage III | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Regional Du Cancer De Montpellier
- Sponsor organisation
- Institut Regional Du Cancer De Montpellier
- Address
- 208 Avenue Des Apothicaires
- City
- Montpellier Cedex 5
- Postcode
- 34298
- Country
- France
Scientific contact point
- Organisation
- Institut Regional Du Cancer De Montpellier
- Contact name
- Pr Eric Assenat
Public contact point
- Organisation
- Institut Regional Du Cancer De Montpellier
- Contact name
- Chloé Janiszewski
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 160 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
oncology department, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Regional De Marseille
oncology department, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier De La Cote Basque
oncology department, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Polyclinique Bordeaux Nord Aquitaine
oncology department, 15 Rue Claude Boucher, Cs 31396, Bordeaux Cedex
Clinique Pasteur Lanroze
oncology department, 32 Rue Auguste Kervern, 29200, Brest
Centre Francois Baclesse
oncol, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Dijon
oncology department, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Departemental Vendee
oncology department, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Hopital Saint Joseph
oncology department, 26 Boulevard De Louvain, 13008, Marseille
Hopital Europeen Marseille
oncology department, 6 Rue Desiree Clary, 13003, Marseille
Hopital Saint Louis
oncology department, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier De Perpignan
oncology department, 20 Avenue Du Languedoc, Cs 49954, Perpignan Cedex
Centre Hospitalier Annecy Genevois
oncology department, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Institut Godinot
oncology department, 1 Rue Du General Koenig, 51100, Reims
Centre De Lutte Contre Le Cancer Eugene Marquis
oncology department, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Groupe Hospitalier Rance Emeraude
oncology department, 1 Rue De La Marne, 35403, Saint-Malo Cedex
Institut De Cancerologie Strasbourg Europe
oncology department, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Hospitalier Regional Universitaire De Tours
oncology department, Avenue De La Republique, 37170, Chambray Les Tours
CHRU De Nancy
oncology department, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Institut De Cancerologie De Lorraine
oncology department, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Centre Hospitalier Universitaire De Montpellier
oncology department, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
CHU De Martinique
oncology department, P. O. Box 90632, 97261, Fort De France Cedex
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-01 | France | Acceptable 2024-08-08
|
2024-08-22 |