Cervical Cancer
Conditions
Interventions
Test group:Perform Primordial Unit Hysterectomy after Neoadjuvant Chemotherapy
Sponsors
The Second Hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participating in this study and signing informed consent forms. 2.Age between 18 and 75 years old. 3.Preoperative diagnosis of cervical cancer stage IB1, IB2, and IIA1 (FIGO 2018). 4.No history of prior chemotherapy or radiotherapy. 5.ECOG score of 0 to 1. 6.Expected survival of more than 6 months. 7.Reproductive-age women must have pregnancy test (serum or urine) with negative results within 7 days before enrollment and agree to use appropriate contraceptive methods during the trial. 8.Determined by the investigator that candidates have no absolute surgical contraindications, able to tolerate surgical treatment, and willing to adhere to the trial protocol.
Exclusion criteria
Exclusion criteria: 1.Active or uncontrolled severe infection. 2.Cirrhosis, decompensated liver disease. 3.History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases. 4.Chronic renal insufficiency and renal failure. 5.Patients with other malignancies requiring treatment and/or diagnosed within 5 years. 6.Myocardial infarction, severe arrhythmias, and =2-grade congestive heart failure (NYHA). 7.Patients who have undergone pelvic arterial embolization. 8.Patients previously treated with radiotherapy for pelvic malignancies. 9.Patients who have undergone subtotal or radical hysterectomy. 10.History of severe allergic reactions to platinum-containing chemotherapy drugs. 11.Presence of comorbidities requiring the use of drugs with significant hepatorenal impairment during treatment, such as tuberculosis. 12.Patients who cannot understand the experimental content and cannot cooperate or refuse to sign informed consent forms. 13.Patients with accompanying diseases or other special circumstances that pose serious risks to patient safety or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS(disease-free survival rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 years' overall survival ;5 years' overall survival ;perioperative SCC;perioperative Hb;operation time;intraoperative blood loss;postoperative Hb;hospital stay;postoperative complications;local recurrence;distant metastasis;postoperative SCC; | — |
Countries
China
Contacts
Public ContactJun Wang
The Second Hospital of Dalian Medical University
Outcome results
None listed