Status:
RECRUITING
Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer
Lead Sponsor:
Chongqing University Cancer Hospital
Conditions:
Locally Advanced Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief 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 stagi...
Detailed Description
All eligible patients will be divided into the following two treatment groups nonrandomly. Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Activity or uncontrol severe infection;
- Liver cirrhosis or other decompensated liver disease;
- A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
- Chronic renal insufficiency or renal failure;
- Other malignancies were diagnosed within five years or needed treatments;
- Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
- The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
- A history of pelvic artery embolization;
- A history of pelvic radiotherapy;
- A history of partial hysterectomy or radical hysterectomy;
- A history of severe allergic reaction to platinum drugs;
- The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
- Patients who cannot understand the research regimen and refuse to sign the informed consent form;
- Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
1956 Patients enrolled
Trial Details
Trial ID
NCT05378087
Start Date
June 27 2022
End Date
December 31 2032
Last Update
August 31 2023
Active Locations (1)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000