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

Sponsor
UNICANCER (Other)
Overall Status
Terminated
CT.gov ID
NCT01363466
Collaborator
(none)
61
Enrollment
35
Locations
2
Arms
42.1
Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: hysterectomy
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
May 1, 2003
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: with hysterectomy

Procedure: hysterectomy
No Intervention: without hysterectomy

Outcome Measures

Primary Outcome Measures

  1. Relapse free survival [from randomization to relapse or last contact (up to 3 years)]

    There is a follow-up period of 3 years.

Secondary Outcome Measures

  1. Overall Survival [From randomisation to death or last contact (up to 3 years)]

    There is a follow-up period of 3 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Clinique Axium Aix-en-Provence France 13100
2 Polyclinique du Parc Rambot Aix-en-Provence France 13100
3 Clinique Sainte Thérèse de l'enfant Jésus Amiens France 80039
4 Centre Hospitalier Universitaire Amiens France 80054
5 Centre Paul Papin Angers France 49033
6 Centre Hospitalier de Beauvais Beauvais France 60021
7 Institut Bergonié Bordeaux France 33076
8 Centre Hospitalier Nord Deux-Sèvres Bressuire Cedex France 79302
9 Centre Hospitalier Universitaire de Brest Brest France 29609
10 Centre Hospitalier Intercommunal Créteil France 94010
11 Centre Georges-François Leclerc Dijon France 21034
12 Centre Hospitalier de Fontainebleau Fontainebleau France 77305
13 Hôpital Hotel-Dieu Lyon Cedex 02 France 69288
14 Centre Hospitalier Edouard Herriot Lyon France 69437
15 Centre Hospitalier Lyon Sud Lyon France 69495
16 Institut paoli Calmettes Marseille Cedex 09 France 13273
17 Hôpital de la conception Marseille cedex 5 France 13385
18 Centre Hospitalier Régional Universitaire La Timone Marseille France 13385
19 Centre Hospitalier Régional Universitaire Hôpital Nord Marseille France 13915
20 Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve Montpellier France 34295
21 Centre Val d'Aurelle-Paul Lamarque Montpellier France 34298
22 Centre hospitalier des Pays de Morlaix Morlaix France 29205
23 Centre René Gauducheau Nantes France 44805
24 Hôpital de la Source Orléans France 45067
25 Hôpital des Diaconnesses Paris Cedex 12 France 75571
26 Hôpital Européen Georges Pompidou Paris Cedex 15 France 75908
27 Centre Hospitalier Universitaire Jean Bernard Poitiers Cedex France 86021
28 Polyclinique de Courlancy Reims France 51100
29 Clinique Mutualiste de la Sagesse Rennes Cedex France 35013
30 Centre Universitaire Hospitalier- Hôpital Sud Rennes France 35203
31 Centre Henri Becquerel Rouen France 76038
32 Centre René Huguenin Saint-Cloud France 92210
33 Institut Claudius Régaud Toulouse Cedex France 31052
34 Centre Hospitalier Bretonneau Tours France 37044
35 Institut Gustave Roussy Villejuif France 94805

Sponsors and Collaborators

  • UNICANCER

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01363466
Other Study ID Numbers:
  • GYNECO 02/0108
First Posted:
Jun 1, 2011
Last Update Posted:
Jun 1, 2011
Last Verified:
May 1, 2011
Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous

Study Results

No Results Posted as of Jun 1, 2011