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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Procedure: QM-C Hysterectomy; Procedure: QM-B Hysterectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 538
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunlin Chen, Doctor; Phone Number: 008613725263051; Email: jieru@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515
      • Contact: Chunlin Chen, Doctor; Phone Number: 8602062787562; Email: jieru@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: QM-C Hysterectomy	Procedure: QM-C Hysterectomy; 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.; Other Names: Type III radical hysterectomy; Radical hysterectomy; Type C radical hysterectomy
Experimental: QM-B Hysterectomy	Procedure: QM-B Hysterectomy; 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.; Other Names: Type II radical hysterectomy; Modified radical hysterectomy; Type B radical hysterectomy

What is the study measuring?

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
Costs	Compare costs between groups	6 months from surgery
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

Collaborators and Investigators

• Sponsor: Southern Medical University, China
• Investigators: Study Chair: Chunlin Chen, Doctor, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Abdominal; Cervical cancer; Hysterectomy; QM-B; QM-C; Oncology outcome; Radical Hysterectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: NFEC-2020-175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No