QM-B and QM-C Hysterectomy for Early Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial Comparing the Oncology Outcome and Safety of QM-B and QM-C Hysterectomy for Early Cervical Cancer

Conditions
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Uterine Cervical Neoplasms

Intervention / Treatment
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* Procedure: QM-C Hysterectomy
* Procedure: QM-B Hysterectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QM-C Hysterectomy<br>QM-C Hysterectomy | Procedure: QM-C Hysterectomy<br>* This operation corresponds to the classical radical hysterectomy. The lateral border is defined as the medial aspect of the internal iliac artery and vein. Transection of the rectovaginal and rectouterine ligaments is performed at the rectum. Transection of the ventral parametrium ligament is performed at the bladder. Both the vesicouterine and vesicovaginal ligaments are resected. The ureter is completely mobilized and lateralized. The length of the vaginal cuff is adjusted to the vaginal extent of the tumor.<br>* Other names: Type C radical hysterectomy;|
| Experimental: QM-B Hysterectomy<br>QM-B Hysterectomy | Procedure: QM-B Hysterectomy<br>* Type B is the modified radical hysterectomy. The ureter is unroofed and mobilized laterally, permitting transection of the paracervix at the level of the ureteral tunnel. Partial resection of the uterosacral peritoneal fold of the rectouterine ligament (dorsal parametrium) and the vesicouterine (ventral parametrium) ligament also is a standard component of this resection. Approximately 10 mm of the vagina from the caudal edge of the cervix or tumor is resected, without intent to radically resect the paravaginal tissues.<br>* Other names: Type B radical hysterectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of overall survival | Compare treatment equivalence | 5 years from surgery | 
| Rate of disease-free survival | Compare treatment equivalence | 5 years from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Compare operation time between groups by timer | Intra-operatively | 
| Volume of blood loss | Compare blood loss between groups by assessment | Intra-operatively | 
| Rate of blood transfusion | Compare rate of blood transfusion between groups | Intra-operatively | 
| Rate of intraoperative complications | Compare intraoperative complications between groups | Intra-operatively | 
| Rate of postoperative complications | Compare postoperative complications between groups | 6 months from surgery | 
| Quality of life Questionnaires | Compare quality of lifes between groups by questionnaire: EORTC CX24. EORTC CX24 for symptom experience, body imageand sexual/vaginal functioning. The scores of EORTC CX24 range from 0 to 100; a higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms. | 6 months from surgery | 
| Pelvic Floor Distress Inventory Questionnaire | Compare PFDI between groups by questionnaire PFDI-20. The calculation of the total scores of PFDI-20 range from 0 to 300; the higher the score the greater the perceived impact that pelvic floor dysfuntion has on a patient's life. | 5 years from surgery | 
| Costs | Compare costs between groups | 6 months from surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, QM-B, QM-C, Oncology outcome, Safety, Hysterectomy, Radical Hysterectomy, Abdominal