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Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by:
UNICANCER
ClinicalTrials.gov Identifier:
NCT01363466
First received: May 5, 2011
Last updated: May 30, 2011
Last verified: May 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Stage IB2 Cervical Cancer
Stage II Cervical Cancer
Adenocarcinoma
Squamous Cell Carcinoma
Adenosquamous Carcinoma
 Procedure: hysterectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Relapse free survival [ Time Frame: from randomization to relapse or last contact (up to 3 years) ] [ Designated as safety issue: Yes ]
    There is a follow-up period of 3 years.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From randomisation to death or last contact (up to 3 years) ] [ Designated as safety issue: Yes ]
    There is a follow-up period of 3 years.


Enrollment: 61
Study Start Date: May 2003
Study Completion Date: November 2006
Arms Assigned Interventions
Experimental: with hysterectomy Procedure: hysterectomy
No Intervention: without hysterectomy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363466

Locations
France
Polyclinique du Parc Rambot
Aix-en-Provence, France, 13100
Clinique Axium
Aix-en-Provence, France, 13100
Clinique Sainte Thérèse de l'enfant Jésus
Amiens, France, 80039
Centre Hospitalier Universitaire
Amiens, France, 80054
Centre Paul Papin
Angers, France, 49033
Centre Hospitalier de Beauvais
Beauvais, France, 60021
Institut Bergonié
Bordeaux, France, 33076
Centre Hospitalier Nord Deux-Sèvres
Bressuire Cedex, France, 79302
Centre Hospitalier Universitaire de Brest
Brest, France, 29609
Centre Hospitalier Intercommunal
Créteil, France, 94010
Centre Georges-François Leclerc
Dijon, France, 21034
Centre Hospitalier de Fontainebleau
Fontainebleau, France, 77305
Centre Hospitalier Edouard Herriot
Lyon, France, 69437
Centre Hospitalier Lyon Sud
Lyon, France, 69495
Hôpital Hotel-Dieu
Lyon Cedex 02, France, 69288
Centre Hospitalier Régional Universitaire Hôpital Nord
Marseille, France, 13915
Centre Hospitalier Régional Universitaire La Timone
Marseille, France, 13385
Institut paoli Calmettes
Marseille Cedex 09, France, 13273
Hôpital de la conception
Marseille cedex 5, France, 13385
Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Centre Val d'Aurelle-Paul Lamarque
Montpellier, France, 34298
Centre hospitalier des Pays de Morlaix
Morlaix, France, 29205
Centre René Gauducheau
Nantes, France, 44805
Hôpital de la Source
Orléans, France, 45067
Hôpital des Diaconnesses
Paris Cedex 12, France, 75571
Hôpital Européen Georges Pompidou
Paris Cedex 15, France, 75908
Centre Hospitalier Universitaire Jean Bernard
Poitiers Cedex, France, 86021
Polyclinique de Courlancy
Reims, France, 51100
Centre Universitaire Hospitalier- Hôpital Sud
Rennes, France, 35203
Clinique Mutualiste de la Sagesse
Rennes Cedex, France, 35013
Centre Henri Becquerel
Rouen, France, 76038
Centre René Huguenin
Saint-Cloud, France, 92210
Institut Claudius Régaud
Toulouse Cedex, France, 31052
Centre Hospitalier Bretonneau
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Philippe MORICE, Pr Institut Gustave Roussy
  More Information

No publications provided

Responsible Party: Professor Philippe MORICE, Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT01363466     History of Changes
Other Study ID Numbers: GYNECO 02/0108
Study First Received: May 5, 2011
Last Updated: May 30, 2011
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
 Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on June 18, 2013