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

NARecruitingINTERVENTIONAL
Enrollment

1,956

Participants

Timeline

Start Date

June 27, 2022

Primary Completion Date

April 30, 2027

Study Completion Date

December 31, 2032

Conditions
Locally Advanced Cervical Cancer
Interventions
RADIATION

Concurrent chemoradiation

Standard concurrent chemoradiation: A point/HCR-CTV D90 ≥80Gy (+20%) by using IMRT or TOMO technics. Patients with image-positive common iliac lymph nodes or para-aortic lymph nodes receive extended-field EBRT. Brachytherapy should begin after 15-20F external radiotherapy. A radiation dose for the image-positive nodes can range from 55Gy to 60Gy. Five cycles of concurrent platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period one week) and CCRT should be completed within 56 days. CCRT one week later, if the cervix biopsy shows residual tumour and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes in the pelvic and abdominal cavity, three cycles of adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy will be performed (A point/HR-CTV D90 ≤ 96Gy).

PROCEDURE

Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation

Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (height of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation should be performed postoperatively within 28 days.) The chemoradiation is consistent with the image staging group, except for extended-field EBRT determined by pathological positive para-aortic lymph nodes.

Trial Locations (1)

400000

RECRUITING

Chongqing University Cancer Hospital, Chongqing

All Listed Sponsors
lead

Chongqing University Cancer Hospital

OTHER