Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

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:

1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
3. Stage (FIGO2018): IB3, IIA2, IIB-IVA;
4. ECOG score: 0 ~ 1;
5. The expected survival >6 months;
6. 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:

1. Activity or uncontrol severe infection;
2. Liver cirrhosis or other decompensated liver disease;
3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
4. Chronic renal insufficiency or renal failure;
5. Other malignancies were diagnosed within five years or needed treatments;
6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
7. The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
8. A history of pelvic artery embolization;
9. A history of pelvic radiotherapy;
10. A history of partial hysterectomy or radical hysterectomy;
11. A history of severe allergic reaction to platinum drugs;
12. The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
13. Patients who cannot understand the research regimen and refuse to sign the informed consent form;
14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.