The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.
The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
Stage (FIGO2018): IB3, IIA2, IIB-IVA;
ECOG score: 0 ~ 1;
Activity or uncontrol severe infection;
Liver cirrhosis or other decompensated liver disease;
A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
Chronic renal insufficiency or renal failure;
Parallel
Concurrent chemoradiation
RadiationStandard concurrent chemoradiation: A point/HCR-CTV D90 ≥80Gy (+20%) by using IMRT or TOMO technics. Patients with image-positive common iliac lymph nodes or para-aortic lymph nodes receive extended-field EBRT. Brachytherapy should begin after 15-20F external radiotherapy. A radiation dose for the image-positive nodes can range from 55Gy to 60Gy. Five cycles of concurrent platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period one week) and CCRT should be completed within 56 days. CCRT one week later, if the cervix biopsy shows residual tumour and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes in the pelvic and abdominal cavity, three cycles of adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy will be performed (A point/HR-CTV D90 ≤ 96Gy).
Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Procedure/SurgeryOpen/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (height of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation should be performed postoperatively within 28 days.) The chemoradiation is consistent with the image staging group, except for extended-field EBRT determined by pathological positive para-aortic lymph nodes.
PFS
Progression-free survival
OS
3-year and 5-year Overall Survival
Complication
Some conditions caused by surgery or chemoradiation.
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