cervical cancer
Conditions
Interventions
control group:Abdominal conventional radical hysterectomy (QM-C2 type)and pelvic lymph node dissection, with or without abdominal aortic lymph node resection
experimental group:Abdominal nerve-sparing radical hysterectomy (QM-C1 type) and pelvic lymph node dissection, with or without abdominal aortic lymph node resection
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age 18 and above; 2) FIGO 2018 stage IB1 (partial), IB2, ?A1 (tumor >= 2cm, 3,000 cells/mcl; 2. Platelet count> 100,000/mcl; 3. Creatinine<2.0 mg/dL; 4. Bilirubin<1.5 times normal, aspartate aminotransferase/alanine aminotransferase<3 times normal times; 7) ECOG score 0-1 points; 8) Patients with surgical indications; 9) Patients who have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) FIGO 2018 stage is ? B1, cervical stromal invasion (assessed by cervical cone biopsy) 4 cm or MRI assessment of cervical tumor invasion of the adventitia; 3) Cervical adenocarcinoma, non-HPV related, gastric type, clear cell type, mesonephric tubular type, non-specific; 4) Uncontrolled diabetes; 5) Pregnancy; 6) Preoperative bladder dysfunction; 7) Previous neuropathy of any grade, especially peripheral neuropathy; 8) Receiving drugs that may cause nerve damage within 3 months before enrollment, such as oxaliplatin, cisplatin, taxanes or vinblastine, apatinib and other drugs; Currently receiving carbamazepine, phenytoin sodium, sodium valproate, gabapentin, pregabalin, venlafaxine, desvenlafaxine, Milnacipran, duloxetine, tricyclic antidepressants; 9) Patients with mental illness; 10) Patients with contraindications to surgery; 11) Patients with metastatic lesions indicated by routine imaging examinations, pelvic/para-aortic lymphadenopathy (>2cm, or patients with short diameter>1cm, or patients with positive lymph nodes; 12) Patients with severe systemic diseases that are inconsistent with the study (determined by the investigator); 13) Patients with uncontrolled second primary cancer; 14) Patients whose medical compliance and geographical location cannot guarantee adequate follow-up; 15) Patients with a history of pelvic and abdominal radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence pattern and site of the two groups;Incidence of treatment-related complications within 6 months after surgery of the two groups;Quality of life in both groups of patients;Pelvic floor function (bladder function) in both groups of patients;Overall survival; | — |
Countries
China
Contacts
Public ContactTao Zhu
Zhejiang Cancer Hospital
Outcome results
None listed