Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT05709769
Eligibility Criteria:
Inclusion Criteria:
1. Patients received pelvic lymphadenectomy and radical hysterectomy, and pathological diagnosis of CC;
2. Patients had stage IB1-IIA2 CC based on the 2014 FIGO staging system for cervical cancer;
3. Patients received postoperative RT/CRT within one week after admission at the ZJPPH;
4. Patients must have Eastern Cooperative Oncology Group performance status 0-2;
5. No treatments prior to radical surgery;
6. Normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin of ≥ 80g/L (can be transfused with red blood cells pre-study), an white blood cell (WBC) counts of ≥ 3.0×109/L，a neutrophil count of ≥ 2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤ 1.0 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤ 2.5 UNL, Alkaline phosphatase (AKP) ≤5.0 UNL. and no major electrocardiogram abnormalities.
7. Patient does not have a known allergy to platinum (cisplatin or carboplatin) or compounds of similar biologic composition.
8. Patients must be with good compliance and agree to accept nutritional therapy;
9. Informed consent signed. -
Exclusion Criteria:
1. Poor image quality or visible artifacts around the L3 psoas;
2. Prior treatments of chemotherapy or irradiation;
3. Poor bone marrow, liver and kidney functions, which would make chemotherapy or radiotherapy intolerable;
4. Participating in other clinical trials;
5. Pregnancy, breast feeding, or not adopting birth control;
6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
7. The subject has had another active malignancy within the past five years;
8. Poor image quality or visible artifacts around the L3 psoas. -
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05709769
Study Brief:
Protocol Section:
NCT05709769