Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
NCT ID: NCT01363466
Last Updated: 2011-06-01
Study Results
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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TERMINATED
PHASE3
61 participants
INTERVENTIONAL
2003-05-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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with hysterectomy
hysterectomy
without hysterectomy
No interventions assigned to this group
Interventions
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hysterectomy
Eligibility Criteria
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Inclusion Criteria
* 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
* Stage \> II (FIGO 1995) at baseline
* Patient with remaining cervical cancer (after sub-total hysterectomy)
18 Years
70 Years
FEMALE
No
Sponsors
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UNICANCER
OTHER
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
Polyclinique du Parc Rambot
Aix-en-Provence, , France
Clinique Sainte Thérèse de l'enfant Jésus
Amiens, , France
Centre Hospitalier Universitaire
Amiens, , France
Centre Paul Papin
Angers, , France
Centre Hospitalier de Beauvais
Beauvais, , France
Institut Bergonié
Bordeaux, , France
Centre Hospitalier Nord Deux-Sèvres
Bressuire, , France
Centre Hospitalier Universitaire de Brest
Brest, , France
Centre Hospitalier Intercommunal
Créteil, , France
Centre Georges-François Leclerc
Dijon, , France
Centre Hospitalier de Fontainebleau
Fontainebleau, , France
Hôpital Hotel-Dieu
Lyon, , France
Centre Hospitalier Edouard Herriot
Lyon, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Institut paoli Calmettes
Marseille, , France
Centre Hospitalier Régional Universitaire La Timone
Marseille, , France
Hôpital de la conception
Marseille, , France
Centre Hospitalier Régional Universitaire Hôpital Nord
Marseille, , France
Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
Montpellier, , France
Centre Val d'Aurelle-Paul Lamarque
Montpellier, , France
Centre hospitalier des Pays de Morlaix
Morlaix, , France
Centre René Gauducheau
Nantes, , France
Hôpital de la Source
Orléans, , France
Hôpital des Diaconnesses
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Centre Hospitalier Universitaire Jean Bernard
Poitiers, , France
Polyclinique de Courlancy
Reims, , France
Clinique Mutualiste de la Sagesse
Rennes, , France
Centre Universitaire Hospitalier- Hôpital Sud
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre René Huguenin
Saint-Cloud, , France
Institut Claudius Régaud
Toulouse, , France
Centre Hospitalier Bretonneau
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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GYNECO 02/0108
Identifier Type: -
Identifier Source: org_study_id
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