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

NCT04691453 | Unknown DMC

• 1 other identifier: NFEC-2020-175
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical cancer; QM-B; QM-C; Oncology outcome; Safety; Hysterectomy; Radical Hysterectomy; Abdominal

Outcome Measures

Primary Outcomes (2)

• Rate of overall survival

  Compare treatment equivalence

  5 years from surgery

• Rate of disease-free survival

  Compare treatment equivalence

  5 years from surgery

Secondary Outcomes (8)

• Operation time

  Intra-operatively

• Volume of blood loss

  Intra-operatively

• Rate of blood transfusion

  Intra-operatively

• Rate of intraoperative complications

  Intra-operatively

• Rate of postoperative complications

  6 months from surgery

Study Arms (2)

QM-C Hysterectomy

ACTIVE COMPARATOR

QM-C Hysterectomy

Procedure: QM-C Hysterectomy

QM-B Hysterectomy

EXPERIMENTAL

QM-B Hysterectomy

Procedure: QM-B Hysterectomy

Interventions

QM-C Hysterectomy PROCEDURE

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.

Also known as: Type III radical hysterectomy, Radical hysterectomy, Type C radical hysterectomy

QM-C Hysterectomy

QM-B Hysterectomy PROCEDURE

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.

Also known as: Type II radical hysterectomy, Modified radical hysterectomy, Type B radical hysterectomy

QM-B Hysterectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have signed an approved Informed Consent
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Chunlin Chen, Doctor

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Chunlin Chen, Doctor

CONTACT

008613725263051; jieru@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Obstetrics and Gynecology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: December 31, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)