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

NARecruitingINTERVENTIONAL
Enrollment

452

Participants

Timeline

Start Date

January 11, 2021

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2032

Conditions
Cervical Cancer
Interventions
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.

Trial Locations (1)

400030

RECRUITING

Chongqing Cancer Hospital, Chongqing

All Listed Sponsors
collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

collaborator

Jiangxi Provincial Cancer Hospital

OTHER

collaborator

Anhui Provincial Cancer Hospital

OTHER

collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

collaborator

Hebei Medical University Fourth Hospital

OTHER

collaborator

Zhejiang Cancer Hospital

OTHER

collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Fujian Cancer Hospital

OTHER_GOV

collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

collaborator

Cancer Hospital of Guizhou Province

OTHER

collaborator

West China Second University Hospital

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

The Affiliated Ganzhou Hospital of Nanchang University

OTHER

collaborator

First Affiliated Hospital of Gannan Medical University

OTHER

collaborator

Gansu Provincial Maternal and Child Health Care Hospital

OTHER

collaborator

Third Affiliated Hospital of Xinjiang Medical University

OTHER

collaborator

Affiliated Cancer Hospital of Shantou University Medical College

OTHER

collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

collaborator

Fujian Maternity and Child Health Hospital

OTHER

collaborator

Shandong Cancer Hospital and Institute

OTHER

collaborator

Sun Yat-sen University Cancer Hosptial

UNKNOWN

lead

Chongqing University Cancer Hospital

OTHER