Squamous Cell Carcinoma Clinical Trial
Official title:
Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
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).
| 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) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| UNICANCER |
France,
| 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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