Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
72
Countries
1
Sites
31
Patients with a histilogically confirmed diagnosis of cervical squamous or adenosquamous carcinoma stage IB3 if N>=1 or II to IVA with any N stage according to FIGO 2018 and no evidence of metastatic disease (M0), without any prior anti-cancer treatment.
Key facts
- Sponsor
- Asso De Recherche Cancers Gynecologiques
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Dec 2024 → ongoing
- Decision date (initial)
- 2024-09-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with a histilogically confirmed diagnosis of cervical squamous or adenosquamous carcinoma stage IB3 if N>=1 or II to IVA with any N stage according to FIGO 2018 and no evidence of metastatic disease (M0), without any prior anti-cancer treatment.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10008236 | Cervical cancer stage IV | 10029104 |
| 21.1 | LLT | 10008233 | Cervical cancer stage I | 10029104 |
| 21.1 | LLT | 10008234 | Cervical cancer stage II | 10029104 |
| 21.1 | LLT | 10008235 | Cervical cancer stage III | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Asso De Recherche Cancers Gynecologiques
- Sponsor organisation
- Asso De Recherche Cancers Gynecologiques
- Address
- 8 Rue Lamennais
- City
- Paris
- Postcode
- 75008
- Country
- France
Scientific contact point
- Organisation
- Asso De Recherche Cancers Gynecologiques
- Contact name
- Isabelle RAY-COQUARD
Public contact point
- Organisation
- Asso De Recherche Cancers Gynecologiques
- Contact name
- Isabelle RAY-COQUARD
Locations
1 EU/EEA country · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 72 | 31 |
| Rest of world | — | 0 | — |
Investigational sites
Hospices Civils De Lyon
ONCOLOGY, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Oscar Lambret
ONCOLOGY, 3 Rue Frederic Combemale, 59000, Lille
Centre Hospitalier Intercommunal Creteil
ONCOLOGY, 40 Avenue De Verdun, 94010, Creteil Cedex
Societe De Recherche Oncologique Clinique 37
ONCOLOGY, 11 Avenue Du Professeur Alexandre Minkowski, 37170, Chambray-Les-Tours
Centre Hospitalier Universitaire De Lille
ONCOLOGY, Avenue Eugene Avinee, 59037, Lille Cedex
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
ONCOLOGY, 10 Rue Francois Jacob, 22190, Plerin
Sainte Catherine Institut Du Cancer Avignon-Provence
ONCOLOGY, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Institut de Cancérologie de l'Ouest - site de Saint Herblain
ONCOLOGY, Boulevard Jacques Monod, 44805, SAINT HERBLAIN
Institut Curie
ONCOLOGY, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Poitiers
ONCOLOGY, 2 Rue De La Miletrie, 86000, Poitiers
Institut Bergonié
ONCOLOGY, 229 Cours de l'Argonne, 33000, BORDEAUX
Centre Leon Berard
ONCOLOGY, 28 Rue Laennec, 69008, Lyon
Oncopole Claudius Regaud
ONCOLOGY, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Regional Et Universitaire De Brest
ONCOLOGY, 2 Avenue Marechal Foch, 29200, Brest
Centre Hospitalier Universitaire De Dijon
ONCOLOGY, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Saint Etienne
ONCOLOGY, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Groupe Hospitalier Diaconesses Croix Saint Simon
ONCOLOGY, 125 Rue D Avron, 75020, Paris
Institut Gustave Roussy
ONCOLOGY, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Et Universitaire De Limoges
ONCOLOGY, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre De Lutte Contre Le Cancer Eugene Marquis
ONCOLOGY, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Institut De Cancerologie De Lorraine
ONCOLOGY, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Institut Paoli Calmettes
ONCOLOGY, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut De Cancerologie Strasbourg Europe
ONCOLOGY, 17 Rue Albert Calmette, 67200, Strasbourg
CHU de Besançon
ONCOLOGY, 3 Bd Fleming, 25030, Besançon Cedex
Centre Antoine Lacassagne
ONCOLOGY, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Regional Du Cancer De Montpellier
ONCOLOGY, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut De Cancerologie De L Ouest
ONCOLOGY, 15 Rue Andre Boquel, 49100, Angers
Centre Hospitalier Regional Universitaire De Tours
ONCOLOGY, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Francois Baclesse
ONCOLOGY, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centr Georges Francois Leclerc
ONCOLOGY, 1 Rue Professeur Marion, 21000, Dijon
Centre Jean Perrin
ONCOLOGY, 58 Rue Montalembert, 63000, Clermont-Ferrand
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 | 2024-12-11 | 2024-12-11 | 2026-01-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-07 | France | Acceptable 2024-09-19
|
2024-09-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-17 | France | Acceptable 2025-06-02
|
2025-06-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-05 | France | Acceptable | 2025-09-19 |