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

Unicancer

Status and phase: Terminated; Phase 3

Conditions: Adenosquamous Carcinoma; Squamous Cell Carcinoma; Stage IB2 Cervical Cancer; Adenocarcinoma; Stage II Cervical Cancer

Treatments: Procedure: hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01363466

GYNECO 02/0108

Details and patient eligibility

About

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).

Enrollment: 61 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

61 participants in 2 patient groups

with hysterectomy

Experimental group

Treatment:

Procedure: hysterectomy

without hysterectomy

No Intervention group