Overview
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.
Description
All eligible patients will be divided into the following two treatment groups nonrandomly.
Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy).
Surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be conducted within 28 days postoperatively.)
Eligibility
Inclusion Criteria:
- 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;
- The expected survival >6 months;
- The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.
Exclusion Criteria:
- 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;
- Other malignancies were diagnosed within five years or needed treatments;
- Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
- The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
- A history of pelvic artery embolization;
- A history of pelvic radiotherapy;
- A history of partial hysterectomy or radical hysterectomy;
- A history of severe allergic reaction to platinum drugs;
- The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
- Patients who cannot understand the research regimen and refuse to sign the informed consent form;
- Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.