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

Primary Purpose

Uterine Cervical Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
QM-C Hysterectomy
QM-B Hysterectomy
Sponsored by
Southern Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Cervical cancer, QM-B, QM-C, Oncology outcome, Safety, Hysterectomy, Radical Hysterectomy, Abdominal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

QM-C Hysterectomy

QM-B Hysterectomy

Arm Description

QM-C Hysterectomy

QM-B Hysterectomy

Outcomes

Primary Outcome Measures

Rate of overall survival
Compare treatment equivalence
Rate of disease-free survival
Compare treatment equivalence

Secondary Outcome Measures

Operation time
Compare operation time between groups by timer
Volume of blood loss
Compare blood loss between groups by assessment
Rate of blood transfusion
Compare rate of blood transfusion between groups
Rate of intraoperative complications
Compare intraoperative complications between groups
Rate of postoperative complications
Compare postoperative complications between groups
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.
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.
Costs
Compare costs between groups

Full Information

First Posted
October 20, 2020
Last Updated
December 28, 2020
Sponsor
Southern Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04691453
Brief Title
QM-B and QM-C Hysterectomy for Early Cervical Cancer
Acronym
QMBCHECC
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Cervical cancer, QM-B, QM-C, Oncology outcome, Safety, Hysterectomy, Radical Hysterectomy, Abdominal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
538 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QM-C Hysterectomy
Arm Type
Active Comparator
Arm Description
QM-C Hysterectomy
Arm Title
QM-B Hysterectomy
Arm Type
Experimental
Arm Description
QM-B Hysterectomy
Intervention Type
Procedure
Intervention Name(s)
QM-C Hysterectomy
Other Intervention Name(s)
Type III radical hysterectomy, Radical hysterectomy, Type C radical hysterectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
QM-B Hysterectomy
Other Intervention Name(s)
Type II radical hysterectomy, Modified radical hysterectomy, Type B radical hysterectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of overall survival
Description
Compare treatment equivalence
Time Frame
5 years from surgery
Title
Rate of disease-free survival
Description
Compare treatment equivalence
Time Frame
5 years from surgery
Secondary Outcome Measure Information:
Title
Operation time
Description
Compare operation time between groups by timer
Time Frame
Intra-operatively
Title
Volume of blood loss
Description
Compare blood loss between groups by assessment
Time Frame
Intra-operatively
Title
Rate of blood transfusion
Description
Compare rate of blood transfusion between groups
Time Frame
Intra-operatively
Title
Rate of intraoperative complications
Description
Compare intraoperative complications between groups
Time Frame
Intra-operatively
Title
Rate of postoperative complications
Description
Compare postoperative complications between groups
Time Frame
6 months from surgery
Title
Quality of life Questionnaires
Description
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.
Time Frame
6 months from surgery
Title
Pelvic Floor Distress Inventory Questionnaire
Description
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.
Time Frame
5 years from surgery
Title
Costs
Description
Compare costs between groups
Time Frame
6 months from surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlin Chen, Doctor
Phone
008613725263051
Email
jieru@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunlin Chen, Doctor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunlin Chen, Doctor
Phone
8602062787562
Email
jieru@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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