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

Uterine Cervical Neoplasms Clinical Trial

— QMBCHECC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691453
• Other study ID #: NFEC-2020-175
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2020
• Source: Southern Medical University, China
• Contact: Chunlin Chen, Doctor
• Phone: 008613725263051
• Email: jieru[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 538
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of overall survival	Compare treatment equivalence	5 years from surgery
Primary	Rate of disease-free survival	Compare treatment equivalence	5 years from surgery
Secondary	Operation time	Compare operation time between groups by timer	Intra-operatively
Secondary	Volume of blood loss	Compare blood loss between groups by assessment	Intra-operatively
Secondary	Rate of blood transfusion	Compare rate of blood transfusion between groups	Intra-operatively
Secondary	Rate of intraoperative complications	Compare intraoperative complications between groups	Intra-operatively
Secondary	Rate of postoperative complications	Compare postoperative complications between groups	6 months from surgery
Secondary	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
Secondary	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
Secondary	Costs	Compare costs between groups	6 months from surgery