Uterine Cervical NeoplasmsQMBCHECCNCT04691453
QM-B and QM-C Hysterectomy for Early Cervical Cancer
A study testing QM-C Hysterectomy and QM-B Hysterectomy in people with Uterine Cervical Neoplasms, run by Southern Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- QM-C Hysterectomy and QM-B Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515
Guangzhou, Guangdong, 510515
Chunlin Chen, Doctor, 8602062787562, jieru@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- QM-C Hysterectomy, QM-B Hysterectomy
- Keywords
- Cervical cancer, QM-B, QM-C, Oncology outcome, Safety, Hysterectomy, Radical Hysterectomy, Abdominal
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QM-C HysterectomyProcedure or surgery
Also called Type III radical hysterectomy, Radical hysterectomy, Type C radical 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 HysterectomyProcedure or surgery
Also called Type II radical hysterectomy, Modified radical hysterectomy, Type B radical 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.
| Study group | Role | What they receive |
|---|---|---|
| QM-C Hysterectomy | Active comparator | QM-C Hysterectomy Receives: Procedure: QM-C Hysterectomy |
| QM-B Hysterectomy | Experimental | QM-B Hysterectomy Receives: Procedure: QM-B Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of overall survival
Compare treatment equivalence
Measured: 5 years from surgery
Rate of disease-free survival
Compare treatment equivalence
Measured: 5 years from surgery
Secondary outcomes (8)
Operation time
Compare operation time between groups by timer
Measured: Intra-operatively
Volume of blood loss
Compare blood loss between groups by assessment
Measured: Intra-operatively
Rate of blood transfusion
Compare rate of blood transfusion between groups
Measured: Intra-operatively
Rate of intraoperative complications
Compare intraoperative complications between groups
Measured: Intra-operatively
Rate of postoperative complications
Compare postoperative complications between groups
Measured: 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.
Measured: 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.
Measured: 5 years from surgery
Costs
Compare costs between groups
Measured: 6 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Chunlin, Southern Medical University, China
- Investigators
- Chunlin Chen, Doctor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691453
- Sponsor's protocol ID
- NFEC-2020-175
- Acronym
- QMBCHECC
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the Oncology Outcome and Safety of QM-B and QM-C Hysterectomy for Early Cervical Cancer
- ClinicalTrials.gov ID
- NCT04691453
- Acronym / sponsor ID
- QMBCHECC / NFEC-2020-175
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical cancer, QM-B, QM-C, Oncology outcome, Safety, Hysterectomy, Radical Hysterectomy, Abdominal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QM-C Hysterectomy | Active comparator | Procedure: QM-C HysterectomyQM-C Hysterectomy |
| QM-B Hysterectomy | Experimental | Procedure: QM-B HysterectomyQM-B Hysterectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QM-C HysterectomyAlso: Type III radical hysterectomy, Radical hysterectomy, Type C radical hysterectomyThis 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. | Procedure or surgery | QM-C Hysterectomy |
| QM-B HysterectomyAlso: Type II radical hysterectomy, Modified radical hysterectomy, Type B radical hysterectomyType 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. | Procedure or surgery | QM-B Hysterectomy |
Primary outcome
Rate of overall survival
Time frame: 5 years from surgery
Compare treatment equivalence
Rate of disease-free survival
Time frame: 5 years from surgery
Compare treatment equivalence
8 secondary outcomes
Operation time
Time frame: Intra-operatively
Volume of blood loss
Time frame: Intra-operatively
Rate of blood transfusion
Time frame: Intra-operatively
Rate of intraoperative complications
Time frame: Intra-operatively
Rate of postoperative complications
Time frame: 6 months from surgery
Quality of life Questionnaires
Time frame: 6 months from surgery
Pelvic Floor Distress Inventory Questionnaire
Time frame: 5 years from surgery
Costs
Time frame: 6 months from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunlin Chen, Doctor study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QM-C Hysterectomy and QM-B Hysterectomy in people with Uterine Cervical Neoplasms, run by Southern Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlin Chen, Doctor (008613725263051, jieru@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of overall survival (time frame: 5 years from surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.