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

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by:
UNICANCER
ClinicalTrials.gov Identifier:
NCT01363466
First received: May 5, 2011
Last updated: May 30, 2011
Last verified: May 2011
History of Changes

May 5, 2011
May 30, 2011
May 2003
Not Provided
Relapse free survival [ Time Frame: from randomization to relapse or last contact (up to 3 years) ] [ Designated as safety issue: Yes ]
There is a follow-up period of 3 years.
Same as current
Complete list of historical versions of study NCT01363466 on ClinicalTrials.gov Archive Site
Overall Survival [ Time Frame: From randomisation to death or last contact (up to 3 years) ] [ Designated as safety issue: Yes ]
There is a follow-up period of 3 years.
Same as current
Not Provided
Not Provided
 
Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage IB2 Cervical Cancer
  • Stage II Cervical Cancer
  • Adenocarcinoma
  • Squamous Cell Carcinoma
  • Adenosquamous Carcinoma
Procedure: hysterectomy
  • Experimental: with hysterectomy
    Intervention: Procedure: hysterectomy
  • No Intervention: without hysterectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
61
November 2006
Not Provided

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)
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01363466
GYNECO 02/0108
No
Professor Philippe MORICE, Institut Gustave Roussy
UNICANCER
Not Provided
Principal Investigator: Philippe MORICE, Pr Institut Gustave Roussy
UNICANCER
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP