The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)

Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer

This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and/or OS with lymph node dissection before CCRT when compared to CCRT.

All eligible patients will be equally randomized between the 2 following treatment groups (stratified factors: whether para-aortic lymph nodes were image-positive):

Standard treatment group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy ±pembrolizumab).

Experimental group: open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation±pembrolizumab. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation ±pembrolizumab will be performed postoperatively within 28 days.)

Inclusion Criteria:

1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
2. Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm
3. ECOG score 0~1
4. Expected survival over 6 months
5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
6. No surgical contraindication

Exclusion Criteria:

1. Activity or uncontrol severe infection
2. Active hepatitis B, Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease
4. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressive medications). Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) were not counted as systemic therapies, and subjects were permitted to use these therapies
5. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
6. Chronic renal insufficiency or renal failure
7. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
8. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
9. Has had an allogenic tissue/solid organ transplant
10. A history of pelvic artery embolization
11. A history of pelvic radiotherapy
12. A history of partial hysterectomy or radical hysterectomy
13. A history of immunotherapy or undergoing immunotherapy
14. A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and/or any excipients
15. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis