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Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer


Phase 3
18 Years
70 Years
Not Enrolling
Female
Stage IB2 Cervical Cancer, Stage II Cervical Cancer, Adenocarcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma

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Trial Information

Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse free survival

Outcome Description:

There is a follow-up period of 3 years.

Outcome Time Frame:

from randomization to relapse or last contact (up to 3 years)

Safety Issue:

Yes

Principal Investigator

Philippe MORICE, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Committee for the Protection of Personnes

Study ID:

GYNECO 02/0108

NCT ID:

NCT01363466

Start Date:

May 2003

Completion Date:

November 2006

Related Keywords:

  • Stage IB2 Cervical Cancer
  • Stage II Cervical Cancer
  • Adenocarcinoma
  • Squamous Cell Carcinoma
  • Adenosquamous Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Carcinoma, Adenosquamous

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