Status:
UNKNOWN
QM-B and QM-C Hysterectomy for Early Cervical Cancer
Lead Sponsor:
Southern Medical University, China
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
18-65 years
Phase:
NA
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...
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 ce...
Eligibility Criteria
Inclusion
- Patients who have signed an approved Informed Consent
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT04691453
Start Date
January 1 2021
End Date
January 1 2025
Last Update
December 31 2020
Active Locations (1)
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1
Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515
Guangzhou, Guangdong, China, 510515