Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer
Who is this study for? Adult female patients with Stage IIIC Cervical Squamous Cell Carcinoma, Adenocarcinoma, or Adenosquamous Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
• 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
• No surgical contraindication
Locations
Other Locations
China
Chongqing Cancer Hospital
RECRUITING
Chongqing
Contact Information
Primary
Dongling Zou, M.D.
cqzl_zdl@163.com
13657690699
Time Frame
Start Date: 2021-01-11
Estimated Completion Date: 2032-08
Participants
Target number of participants: 452
Treatments
Active_comparator: Standard treatment group
Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).
Experimental: Experimental group
Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).
Related Therapeutic Areas
Sponsors
Collaborators: Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital, Sun Yat-sen University Cancer Hosptial, The Affiliated Ganzhou Hospital of Nanchang University, Shandong Cancer Hospital and Institute, Cancer Hospital of Guizhou Province, The Second Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Gannan Medical University, Third Affiliated Hospital of Xinjiang Medical University, Fujian Maternity and Child Health Hospital, West China Second University Hospital, Women's Hospital School Of Medicine Zhejiang University, Sichuan Cancer Hospital and Research Institute, Qilu Hospital of Shandong University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Obstetrics & Gynecology Hospital of Fudan University, Affiliated Cancer Hospital of Shantou University Medical College, Zhejiang Cancer Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Tongji Hospital, Fujian Cancer Hospital, Anhui Provincial Cancer Hospital
Leads: Chongqing University Cancer Hospital