Last updated: August 29, 2023
Sponsor: Chongqing University Cancer Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Cervical Cancer
Uterine Disorders
Treatment
Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Concurrent chemoradiation
Clinical Study ID
NCT05378087
CQGOG0106
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patients with good compliance, voluntarily signed the informed consent form andparticipated 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 forwomen of childbearing age, who must take contraception during the trial.
Exclusion
Exclusion Criteria:
- Activity or uncontrol severe infection;
- Liver cirrhosis or other decompensated liver disease;
- A history of immune deficiency, including HIV positive or a congenitalimmunodeficiency 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 kidneyfunction, such as tuberculosis;
- Patients who cannot understand the research regimen and refuse to sign the informedconsent form;
- Other concomitant diseases or special conditions seriously endanger the patient'shealth or interfere with the trial.
Study Design
Total Participants: 1956
Treatment Group(s): 2
Primary Treatment: Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Phase:
Study Start date:
June 27, 2022
Estimated Completion Date:
December 31, 2032
Study Description
Connect with a study center
Chongqing University Cancer Hospital
Chongqing, Chongqing 400000
ChinaActive - Recruiting
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