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.
Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm
ECOG score 0~1
Expected survival over 6 months
Activity or uncontrol severe infection
Active hepatitis B, Liver cirrhosis, Decompensated liver disease
History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease
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
Parallel
Lymph node dissection
Procedure/SurgeryOpen/minimaly invasive pelvic and para-aortic lymph node dissection
Standard chemoradiation±pembrolizumab
Radiation1\. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 \< 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.
Chemoradiation± pembrolizumab
Radiation1\. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 \< 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.
PFS
Progression-free survival
OS
Overall survival
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Chongqing University Cancer Hospital
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Fujian Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Cancer Hospital of Guizhou Province
Collaborator
West China Second University Hospital
Collaborator
Tongji Hospital
Collaborator
The Affiliated Ganzhou Hospital of Nanchang University
Collaborator
First Affiliated Hospital of Gannan Medical University
Collaborator
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Third Affiliated Hospital of Xinjiang Medical University
Collaborator
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
Fujian Maternity and Child Health Hospital
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
