The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma (EC-02)

Ding Ma

Status: Active, not recruiting

Conditions: Endometrial Neoplasms

Treatments: Procedure: BPLND; Procedure: TH/BSO; Procedure: TH

Study type: Interventional

Funder types: Other

Identifiers

NCT01820884

2012-GYN/EC-02

Details and patient eligibility

About

This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FIGO stage: ⅠA, endometrial carcinoma;
• Female, Chinese women;
• premenopausal women；
• ≤ 50 years old;
• Pathological diagnosis by curettage/hysteroscopy : G1
• No prior treatment;
• Provide written informed consent.

Exclusion criteria

• The suspicious metastasis of ovarian;
• Family history of ovarian cancer;
• Suffering from other malignancies;
• Concurrently participating in other clinical trials;
• Unable or unwilling to sign informed consents;
• Unable or unwilling to abide by protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Total Hysterectomy (TH)

Experimental group

Description:

Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).

Treatment:

Procedure: BPLND

Procedure: TH

TH and bilateral salpingo-oophorectomy (TH/BSO)

Active Comparator group

Description:

Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.

Treatment:

Procedure: BPLND

Procedure: TH/BSO