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

Primary Purpose

Stage IB2 Cervical Cancer, Stage II Cervical Cancer, Adenocarcinoma

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
hysterectomy
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IB2 Cervical Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Clinique Axium
  • Polyclinique du Parc Rambot
  • Clinique Sainte Thérèse de l'enfant Jésus
  • Centre Hospitalier Universitaire
  • Centre Paul Papin
  • Centre Hospitalier de Beauvais
  • Institut Bergonié
  • Centre Hospitalier Nord Deux-Sèvres
  • Centre Hospitalier Universitaire de Brest
  • Centre Hospitalier Intercommunal
  • Centre Georges-François Leclerc
  • Centre Hospitalier de Fontainebleau
  • Hôpital Hotel-Dieu
  • Centre Hospitalier Edouard Herriot
  • Centre Hospitalier Lyon Sud
  • Institut paoli Calmettes
  • Hôpital de la conception
  • Centre Hospitalier Régional Universitaire La Timone
  • Centre Hospitalier Régional Universitaire Hôpital Nord
  • Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
  • Centre Val d'Aurelle-Paul Lamarque
  • Centre hospitalier des Pays de Morlaix
  • Centre René Gauducheau
  • Hôpital de la Source
  • Hôpital des Diaconnesses
  • Hôpital Européen Georges Pompidou
  • Centre Hospitalier Universitaire Jean Bernard
  • Polyclinique de Courlancy
  • Clinique Mutualiste de la Sagesse
  • Centre Universitaire Hospitalier- Hôpital Sud
  • Centre Henri Becquerel
  • Centre René Huguenin
  • Institut Claudius Régaud
  • Centre Hospitalier Bretonneau
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

with hysterectomy

without hysterectomy

Arm Description

Outcomes

Primary Outcome Measures

Relapse free survival
There is a follow-up period of 3 years.

Secondary Outcome Measures

Overall Survival
There is a follow-up period of 3 years.

Full Information

First Posted
May 5, 2011
Last Updated
May 30, 2011
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT01363466
Brief Title
Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
Official Title
Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IB2 Cervical Cancer, Stage II Cervical Cancer, Adenocarcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
with hysterectomy
Arm Type
Experimental
Arm Title
without hysterectomy
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
hysterectomy
Primary Outcome Measure Information:
Title
Relapse free survival
Description
There is a follow-up period of 3 years.
Time Frame
from randomization to relapse or last contact (up to 3 years)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
There is a follow-up period of 3 years.
Time Frame
From randomisation to death or last contact (up to 3 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe MORICE, Pr
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Axium
City
Aix-en-Provence
ZIP/Postal Code
13100
Country
France
Facility Name
Polyclinique du Parc Rambot
City
Aix-en-Provence
ZIP/Postal Code
13100
Country
France
Facility Name
Clinique Sainte Thérèse de l'enfant Jésus
City
Amiens
ZIP/Postal Code
80039
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Hospitalier de Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier Nord Deux-Sèvres
City
Bressuire Cedex
ZIP/Postal Code
79302
Country
France
Facility Name
Centre Hospitalier Universitaire de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Hospitalier de Fontainebleau
City
Fontainebleau
ZIP/Postal Code
77305
Country
France
Facility Name
Hôpital Hotel-Dieu
City
Lyon Cedex 02
ZIP/Postal Code
69288
Country
France
Facility Name
Centre Hospitalier Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Institut paoli Calmettes
City
Marseille Cedex 09
ZIP/Postal Code
13273
Country
France
Facility Name
Hôpital de la conception
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Régional Universitaire La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Régional Universitaire Hôpital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Val d'Aurelle-Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre hospitalier des Pays de Morlaix
City
Morlaix
ZIP/Postal Code
29205
Country
France
Facility Name
Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital de la Source
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Hôpital des Diaconnesses
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Centre Hospitalier Universitaire Jean Bernard
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Polyclinique de Courlancy
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Clinique Mutualiste de la Sagesse
City
Rennes Cedex
ZIP/Postal Code
35013
Country
France
Facility Name
Centre Universitaire Hospitalier- Hôpital Sud
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre René Huguenin
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut Claudius Régaud
City
Toulouse Cedex
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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