QM-B and QM-C Hysterectomy for Early Cervical Cancer (QMBCHECC)

Southern Medical University

Status: Enrolling

Conditions: Uterine Cervical Neoplasms

Treatments: Procedure: QM-B Hysterectomy; Procedure: QM-C Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04691453

NFEC-2020-175

Details and patient eligibility

About

The goal of this clinical research study is to compare the long-term outcomes and safety of Querleu-Morrow-B(QM-B) and Querleu-Morrow-C(QM-C) hysterectomy for early cervical cancer. In this study, the surgical approach for QM-B and QM-C hysterectomy will be abdominal.

Full description

Primary Objective:

To compare 5-year overall survival and 5-year disease-free survival amongst patients who undergo a QM-B hysterectomy versus those who undergo a QM-C hysterectomy for early stage cervical cancer.

Secondary Objectives:

Compare operation time between arms. Compare blood loss between arms. Compare blood transfusion between arms. Compare intraoperative complications between arms. Compare postoperative complications between arms. Compare quality of lifes between arms.

Enrollment: 538 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have signed an approved Informed Consent
• 18.5≤BMI<28
• Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
• Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, stage IB1, stage IB2, or stage IIA1 disease(FIGO 2018).
• Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1.
• Patients undergoing the Non-Fertility-Sparing surgery.
• Patients undergoing abdominal surgery.

Exclusion criteria

• The life expectancy of the patient is less than 6 months.
• Patients with serious medical diseases.
• Patients with contraindications to surgery or anesthesia.
• Preoperative imaging studies suggest metastasis to pelvic lymph nodes or para-aortic lymph nodes.
• Patient asks to preserve fertility.
• The patient requested direct radiation therapy.
• Patients with adjuvant radiotherapy or chemotherapy before surgery.
• Patients judged by the investigator to be unsuitable to participate in this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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538 participants in 2 patient groups

QM-C Hysterectomy

Active Comparator group

Description:

QM-C Hysterectomy

Treatment:

Procedure: QM-C Hysterectomy

QM-B Hysterectomy

Experimental group

Description:

QM-B Hysterectomy

Treatment:

Procedure: QM-B Hysterectomy