NCT01363466TerminatedPhase 3
Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- UNICANCER
- Enrollment
- 61
- Locations
- 35
- Primary Endpoint
- Relapse free survival
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
with hysterectomy
Experimental
Intervention: hysterectomy (Procedure)
without hysterectomy
No Intervention
Outcomes
Primary Outcomes
Relapse free survival
Time Frame: from randomization to relapse or last contact (up to 3 years)
There is a follow-up period of 3 years.
Secondary Outcomes
- Overall Survival(From randomisation to death or last contact (up to 3 years))
Investigators
Study Sites (35)
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