cervical cancer
Conditions
Interventions
intervention group:Neoadjuvant chemotherapy followed by vaginal radical trachelectomy
Sponsors
Obstetrics and Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria for neo-adjuvant chemotherapy: 1) Aged > 18 and <= 40 years; 2) Invasive cervical cancer: adenocarcinoma, adenosquamous or squamous, grade 1, 2 and 3; 3) Lymphovascular space invasion allowed; 4) 2018 FIGO stage IB2 measuring 2–4 cm (clinical exam and MRI); 5) Pathologically-negative pelvic nodes (based on pre-study lymph node dissection/sentinel lymph node mapping); 6) Desire to preserve fertility potential. 2.Inclusion criteria for fertility-preserving surgery: 1) Completed the planned three cycles of neo-adjuvant chemotherapy; 2) Achieved complete or partial response (<2 cm residual lesion) following neo-adjuvant chemotherapy.
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria for neo-adjuvant chemotherapy: 1) Pregnant women; 2) Patients who have had chemotherapy or radiotherapy for their cancer. 2.Exclusion criteria for fertility-preserving surgery: Nil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free rate;2-year and 5-year overall survival rate;pregnant rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| EORTC QLQ-CX24;surgery complications;Health economics;Safety index;Sex hormone levels;Kupperman index; | — |
Countries
China
Contacts
Public ContactKeqin Hua
Obstetrics and Gynecology Hospital of Fudan University
Outcome results
None listed