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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Bergonie
      • 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-François 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
        • Hopital Europeen 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: with hysterectomy
Procedure: hysterectomy
No Intervention: without hysterectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNICANCER

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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