Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
- Conditions
- Stage IB2 Cervical CancerStage II Cervical CancerAdenocarcinomaSquamous Cell CarcinomaAdenosquamous Carcinoma
- Interventions
- Procedure: hysterectomy
- Registration Number
- NCT01363466
- Lead Sponsor
- UNICANCER
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 61
- 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.
- Other tumor histology (neuro-endocrine)
- Stage > II (FIGO 1995) at baseline
- Patient with remaining cervical cancer (after sub-total hysterectomy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description with hysterectomy hysterectomy -
- Primary Outcome Measures
Name Time Method Relapse free survival from randomization to relapse or last contact (up to 3 years) There is a follow-up period of 3 years.
- Secondary Outcome Measures
Name Time Method Overall Survival From randomisation to death or last contact (up to 3 years) There is a follow-up period of 3 years.
Trial Locations
- Locations (35)
Clinique Sainte Thérèse de l'enfant Jésus
🇫🇷Amiens, France
Clinique Axium
🇫🇷Aix-en-Provence, France
Centre Hospitalier Universitaire
🇫🇷Amiens, France
Centre Hospitalier Lyon Sud
🇫🇷Lyon, France
Centre Hospitalier de Beauvais
🇫🇷Beauvais, France
Institut Bergonié
🇫🇷Bordeaux, France
Polyclinique du Parc Rambot
🇫🇷Aix-en-Provence, France
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier Régional Universitaire La Timone
🇫🇷Marseille, France
Centre Georges-François Leclerc
🇫🇷Dijon, France
Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
Centre Val d'Aurelle-Paul Lamarque
🇫🇷Montpellier, France
Centre Hospitalier Nord Deux-Sèvres
🇫🇷Bressuire Cedex, France
Centre Hospitalier Universitaire de Brest
🇫🇷Brest, France
Centre Hospitalier Intercommunal
🇫🇷Créteil, France
Centre Hospitalier de Fontainebleau
🇫🇷Fontainebleau, France
Hôpital Hotel-Dieu
🇫🇷Lyon Cedex 02, France
Centre Hospitalier Edouard Herriot
🇫🇷Lyon, France
Centre Hospitalier Régional Universitaire Hôpital Nord
🇫🇷Marseille, 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
Clinique Mutualiste de la Sagesse
🇫🇷Rennes Cedex, France
Centre Universitaire Hospitalier- Hôpital Sud
🇫🇷Rennes, 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, France
Hôpital de la conception
🇫🇷Marseille cedex 5, France
Institut paoli Calmettes
🇫🇷Marseille Cedex 09, France