Clinical trial NCT04691453: QM-B and QM-C Hysterectomy for Early Cervical Cancer
Official title: Randomized Clinical Trial Comparing the Oncology Outcome and Safety of QM-B and QM-C Hysterectomy for Early Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Cervical Neoplasms
Keywords: Cervical cancer
QM-B
QM-C
Oncology outcome
Safety
Hysterectomy
Radical Hysterectomy
Abdominal
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 538
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of overall survival
timeFrame: 5 years from surgery
measure: Rate of disease-free survival
timeFrame: 5 years from surgery
Secondary outcomes:
measure: Operation time
timeFrame: Intra-operatively
measure: Volume of blood loss
timeFrame: Intra-operatively
measure: Rate of blood transfusion
timeFrame: Intra-operatively
measure: Rate of intraoperative complications
timeFrame: Intra-operatively
measure: Rate of postoperative complications
timeFrame: 6 months from surgery
measure: Quality of life Questionnaires
timeFrame: 6 months from surgery
measure: Pelvic Floor Distress Inventory Questionnaire
timeFrame: 5 years from surgery
measure: Costs
timeFrame: 6 months from surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Chunlin Chen, Doctor
role: STUDY_CHAIR
References: