Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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⁃ The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
⁃ Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
⁃ Stage (FIGO2018): IB3, IIA2, IIB-IVA;
⁃ ECOG score: 0 \
• 1;
⁃ The expected survival \>6 months;
⁃ The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.
Locations
Other Locations
China
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Contact Information
Primary
Dongling Zou, M.D.
cqzl_zdl@163.com
13657690699
Time Frame
Start Date: 2022-06-27
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 1956
Treatments
Active_comparator: Image staging group
Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
Experimental: Surgery staging group
Open/minimally invasive para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
Related Therapeutic Areas
Sponsors
Leads: Chongqing University Cancer Hospital