NCT04555226

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.)

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	Lymph node dissection	Open/minimaly invasive pelvic and para-aortic lymph node dissection
RADIATION	Standard chemoradiation±pembrolizumab	1\. 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.
RADIATION	Chemoradiation± pembrolizumab	1\. 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.

Timeline

• Start date: 2021-01-11
• Primary completion: 2029-08-01
• Completion: 2032-08-01
• First posted: 2020-09-18
• Last updated: 2025-09-02

Locations

1 site across 1 country: China