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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01363466
Other study ID # GYNECO 02/0108
Secondary ID
Status Terminated
Phase Phase 3
First received May 5, 2011
Last updated May 30, 2011
Start date May 2003
Est. completion date November 2006

Study information

Verified date May 2011
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).


Recruitment information / eligibility

Status Terminated
Enrollment 61
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- operable Stage IB2/II Cervical Cancer

- adenocarcinoma, squamous cell or adenosquamous carcinoma

- Patient between 18 and 70 years old

- No lombo-aortic lymph node invasion at baseline

- Previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles)

- Followed by a 15 grays utero-vaginal brachytherapy, eventually combined with a 6th cycle of chemotherapy (cisplatin 40 mg/m2)

- with a pelvic boost if lymph node or parametrial invasion

- No macroscopic residual tumor after 6 to 8 weeks after brachytherapy.

Exclusion Criteria:

- Other tumor histology (neuro-endocrine)

- Stage > II (FIGO 1995) at baseline

- Patient with remaining cervical cancer (after sub-total hysterectomy)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
hysterectomy


Locations

Country Name City State
France Clinique Axium Aix-en-Provence
France Polyclinique du Parc Rambot Aix-en-Provence
France Centre Hospitalier Universitaire Amiens
France Clinique Sainte Thérèse de l'enfant Jésus Amiens
France Centre Paul Papin Angers
France Centre Hospitalier de Beauvais Beauvais
France Institut Bergonié Bordeaux
France Centre Hospitalier Nord Deux-Sèvres Bressuire Cedex
France Centre Hospitalier Universitaire de Brest Brest
France Centre Hospitalier Intercommunal Créteil
France Centre Georges-François Leclerc Dijon
France Centre Hospitalier de Fontainebleau Fontainebleau
France Centre Hospitalier Edouard Herriot Lyon
France Centre Hospitalier Lyon Sud Lyon
France Hôpital Hotel-Dieu Lyon Cedex 02
France Centre Hospitalier Régional Universitaire Hôpital Nord Marseille
France Centre Hospitalier Régional Universitaire La Timone Marseille
France Institut paoli Calmettes Marseille Cedex 09
France Hôpital de la conception Marseille cedex 5
France Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve Montpellier
France Centre Val d'Aurelle-Paul Lamarque Montpellier
France Centre hospitalier des Pays de Morlaix Morlaix
France Centre René Gauducheau Nantes
France Hôpital de la Source Orléans
France Hôpital des Diaconnesses Paris Cedex 12
France Hôpital Européen Georges Pompidou Paris Cedex 15
France Centre Hospitalier Universitaire Jean Bernard Poitiers Cedex
France Polyclinique de Courlancy Reims
France Centre Universitaire Hospitalier- Hôpital Sud Rennes
France Clinique Mutualiste de la Sagesse Rennes Cedex
France Centre Henri Becquerel Rouen
France Centre René Huguenin Saint-Cloud
France Institut Claudius Régaud Toulouse Cedex
France Centre Hospitalier Bretonneau Tours
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse free survival There is a follow-up period of 3 years. from randomization to relapse or last contact (up to 3 years) Yes
Secondary Overall Survival There is a follow-up period of 3 years. From randomisation to death or last contact (up to 3 years) Yes
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