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

May 30, 2011 updated by: UNICANCER

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France, 13100
        • Polyclinique du parc Rambot
      • Aix-en-Provence, France, 13100
        • Clinique Axium
      • Amiens, France, 80039
        • Clinique Sainte Thérèse de l'enfant Jésus
      • Amiens, France, 80054
        • Centre Hospitalier Universitaire
      • Angers, France, 49033
        • Centre Paul Papin
      • Beauvais, France, 60021
        • Centre Hospitalier de Beauvais
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Bressuire Cedex, France, 79302
        • Centre Hospitalier Nord Deux-Sèvres
      • Brest, France, 29609
        • Centre Hospitalier Universitaire de Brest
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal
      • Dijon, France, 21034
        • Centre Georges-Francois Leclerc
      • Fontainebleau, France, 77305
        • Centre Hospitalier de Fontainebleau
      • Lyon, France, 69495
        • Centre Hospitalier Lyon Sud
      • Lyon, France, 69437
        • Centre Hospitalier Edouard Herriot
      • Lyon Cedex 02, France, 69288
        • Hôpital Hôtel-Dieu
      • Marseille, France, 13385
        • Centre Hospitalier Régional Universitaire La Timone
      • Marseille, France, 13915
        • Centre Hospitalier Régional Universitaire Hôpital Nord
      • Marseille Cedex 09, France, 13273
        • Institut Paoli Calmettes
      • Marseille cedex 5, France, 13385
        • Hopital de la Conception
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
      • Montpellier, France, 34298
        • Centre Val D'Aurelle-Paul Lamarque
      • Morlaix, France, 29205
        • Centre hospitalier des pays de Morlaix
      • Nantes, France, 44805
        • Centre Rene Gauducheau
      • Orléans, France, 45067
        • Hôpital de la Source
      • Paris Cedex 12, France, 75571
        • Hôpital des Diaconnesses
      • Paris Cedex 15, France, 75908
        • Hôpital Européen Georges Pompidou
      • Poitiers Cedex, France, 86021
        • Centre Hospitalier Universitaire Jean Bernard
      • Reims, France, 51100
        • Polyclinique de Courlancy
      • Rennes, France, 35203
        • Centre Universitaire Hospitalier- Hôpital Sud
      • Rennes Cedex, France, 35013
        • Clinique Mutualiste de La Sagesse
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Cloud, France, 92210
        • Centre René Huguenin
      • Toulouse Cedex, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37044
        • Centre Hospitalier Bretonneau
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with hysterectomy
Procedure: hysterectomy
No Intervention: without hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse free survival
Time Frame: from randomization to relapse or last contact (up to 3 years)
There is a follow-up period of 3 years.
from randomization to relapse or last contact (up to 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomisation to death or last contact (up to 3 years)
There is a follow-up period of 3 years.
From randomisation to death or last contact (up to 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Philippe MORICE, Pr, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 30, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 30, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYNECO 02/0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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