Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Conditions
Interventions
Control group: Traditional radical hysterectomy with pelvic lymph node dissection:None
Observation group:total Müllerian duct compartment resection with pelvic lymph node dissection:None
Sponsors
The second hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patient voluntarily participates in this study and has signed an informed consent form; 2.Aged 18 to 75 years; 3.Preoperative diagnosis of cervical cancer stages IB1, IB2, or IIA1 [International Federation of Gynecology and Obstetrics (FIGO 2018)] based on auxiliary examinations; 4.Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 5.Preoperative imaging (MRI, CT, PET-CT) shows no evidence of definite parametrial invasion (i.e., not stage IIB) and no lymph node metastasis; 6.No prior history of radiotherapy or chemotherapy; 7.ECOG performance status score of 0–1; 8.Expected survival > 6 months; 9.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the trial; 10.No absolute contraindications to surgery as determined by the investigator, able to tolerate surgical treatment, and willing to comply with the trial protocol;
Exclusion criteria
Exclusion criteria: 1.Preoperative imaging (MRI, CT, PET-CT) indicating suspected lymph node metastasis, parametrial invasion, or distant metastasis; 2.Pathologically confirmed special histological types, such as neuroendocrine tumors, serous carcinoma, gastric-type adenocarcinoma, clear cell carcinoma, or endometrioid adenocarcinoma; 3.Previous radiotherapy for pelvic malignancies; 4.History of partial hysterectomy or radical hysterectomy; 5.Active or uncontrolled severe infection; 6.Liver cirrhosis or decompensated liver disease; 7.Chronic renal insufficiency or renal failure; 8.Myocardial infarction, severe arrhythmia, and congestive heart failureMyocardial infarction, severe arrhythmia, and congestive heart failure >= Grade 2 (New York Heart Association [NYHA] ; 9.Patients with concurrent other malignancies requiring treatment and/or newly diagnosed malignancies within the past 5 years; 10.History of immunodeficiency, including HIV-positive status or other acquired or congenital immunodeficiency disorders; 11.Patients who have undergone pelvic artery embolization; 12.Patients with concomitant conditions requiring treatment with drugs that significantly impair hepatic or renal function, such as tuberculosis; 13.Patients unable to understand the study content, unable to cooperate, or refusing to sign the informed consent form; 14.Patients with concomitant diseases or other special circumstances that pose a serious threat to patient safety or interfere with study completion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Perioperative Complications;5-year overall survival rate; | — |
Countries
China
Contacts
Public ContactJun Wang
The second hospital of Dalian Medical University
Outcome results
None listed