Clinical trial NCT01363466: Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
Official title: Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stage IB2 Cervical Cancer
Stage II Cervical Cancer
Adenocarcinoma
Squamous Cell Carcinoma
Adenosquamous Carcinoma
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Relapse free survival
timeFrame: from randomization to relapse or last contact (up to 3 years)
Secondary outcomes:
measure: Overall Survival
timeFrame: From randomisation to death or last contact (up to 3 years)
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Clinique Axium
city: Aix-en-Provence
country: France
facility: Polyclinique du Parc Rambot
city: Amiens
country: France
facility: Clinique Sainte Thérèse de l'enfant Jésus
city: Amiens
country: France
facility: Centre Hospitalier Universitaire
city: Angers
country: France
facility: Centre Paul Papin
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bressuire Cedex
country: France
facility: Centre Hospitalier Nord Deux-Sèvres
city: Brest
country: France
facility: Centre Hospitalier Universitaire de Brest
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Fontainebleau
country: France
facility: Centre Hospitalier de Fontainebleau
city: Lyon Cedex 02
country: France
facility: Hôpital Hotel-Dieu
city: Lyon
country: France
facility: Centre Hospitalier Edouard Herriot
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Marseille Cedex 09
country: France
facility: Institut paoli Calmettes
city: Marseille cedex 5
country: France
facility: Hôpital de la conception
city: Marseille
country: France
facility: Centre Hospitalier Régional Universitaire La Timone
city: Marseille
country: France
facility: Centre Hospitalier Régional Universitaire Hôpital Nord
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
city: Montpellier
country: France
facility: Centre Val d'Aurelle-Paul Lamarque
city: Morlaix
country: France
facility: Centre hospitalier des Pays de Morlaix
city: Nantes
country: France
facility: Centre René Gauducheau
city: Orléans
country: France
facility: Hôpital de la Source
city: Paris Cedex 12
country: France
facility: Hôpital des Diaconnesses
city: Paris Cedex 15
country: France
facility: Hôpital Européen Georges Pompidou
city: Poitiers Cedex
country: France
facility: Centre Hospitalier Universitaire Jean Bernard
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Rennes Cedex
country: France
facility: Clinique Mutualiste de la Sagesse
city: Rennes
country: France
facility: Centre Universitaire Hospitalier- Hôpital Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: Centre René Huguenin
city: Toulouse Cedex
country: France
facility: Institut Claudius Régaud
city: Tours
country: France
facility: Centre Hospitalier Bretonneau
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Philippe MORICE, Pr
role: PRINCIPAL_INVESTIGATOR
References: