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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01363466

Enrollment

Registered

2011-06-01

Start date

2003-05-31

Completion date

2006-11-30

Last updated

2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Adenosquamous Carcinoma, Squamous Cell Carcinoma, Stage IB2 Cervical Cancer, Stage II Cervical Cancer

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).

Interventions

PROCEDUREhysterectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Relapse free survival	from randomization to relapse or last contact (up to 3 years)	There is a follow-up period of 3 years.

Secondary

Measure	Time frame	Description
Overall Survival	From randomisation to death or last contact (up to 3 years)	There is a follow-up period of 3 years.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026