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

NCT ID: NCT01363466

Last Updated: 2011-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Stage IB2 Cervical Cancer Stage II Cervical Cancer Adenocarcinoma Squamous Cell Carcinoma Adenosquamous Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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with hysterectomy

Group Type EXPERIMENTAL

hysterectomy

Intervention Type PROCEDURE

without hysterectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UNICANCER

OTHER

Sponsor Role lead

Responsible Party

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Institut Gustave Roussy

Principal Investigators

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Philippe MORICE, Pr

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Clinique Axium

Aix-en-Provence, , France

Site Status

Polyclinique du Parc Rambot

Aix-en-Provence, , France

Site Status

Clinique Sainte Thérèse de l'enfant Jésus

Amiens, , France

Site Status

Centre Hospitalier Universitaire

Amiens, , France

Site Status

Centre Paul Papin

Angers, , France

Site Status

Centre Hospitalier de Beauvais

Beauvais, , France

Site Status

Institut Bergonié

Bordeaux, , France

Site Status

Centre Hospitalier Nord Deux-Sèvres

Bressuire, , France

Site Status

Centre Hospitalier Universitaire de Brest

Brest, , France

Site Status

Centre Hospitalier Intercommunal

Créteil, , France

Site Status

Centre Georges-François Leclerc

Dijon, , France

Site Status

Centre Hospitalier de Fontainebleau

Fontainebleau, , France

Site Status

Hôpital Hotel-Dieu

Lyon, , France

Site Status

Centre Hospitalier Edouard Herriot

Lyon, , France

Site Status

Centre Hospitalier Lyon Sud

Lyon, , France

Site Status

Institut paoli Calmettes

Marseille, , France

Site Status

Centre Hospitalier Régional Universitaire La Timone

Marseille, , France

Site Status

Hôpital de la conception

Marseille, , France

Site Status

Centre Hospitalier Régional Universitaire Hôpital Nord

Marseille, , France

Site Status

Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve

Montpellier, , France

Site Status

Centre Val d'Aurelle-Paul Lamarque

Montpellier, , France

Site Status

Centre hospitalier des Pays de Morlaix

Morlaix, , France

Site Status

Centre René Gauducheau

Nantes, , France

Site Status

Hôpital de la Source

Orléans, , France

Site Status

Hôpital des Diaconnesses

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Centre Hospitalier Universitaire Jean Bernard

Poitiers, , France

Site Status

Polyclinique de Courlancy

Reims, , France

Site Status

Clinique Mutualiste de la Sagesse

Rennes, , France

Site Status

Centre Universitaire Hospitalier- Hôpital Sud

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre René Huguenin

Saint-Cloud, , France

Site Status

Institut Claudius Régaud

Toulouse, , France

Site Status

Centre Hospitalier Bretonneau

Tours, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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GYNECO 02/0108

Identifier Type: -

Identifier Source: org_study_id

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