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:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT03622827
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 70 years.
* Histologically confirmed adenocarcinoma or squamous cervical carcinomas.
* Chest CT scan and ultrasound must be done prior to surgery as to rule out distant metastasis.
* Operable patients with clinical diagnosis of FIGO stage IB-IIA cervical cancer.
* Complete radical hysterectomy of cervical cancer is mandatory. All gross diseases must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Para-aortic lymph node sampling is performed according to gynaecologist decision.
* Patients with one of these risk factors:positive pelvic nodes, parametrial invasion, positive surgical margin.OR patients with at least two of following risk factors: tumor size≥4cm,lymphovascular space invasion,stromal invasion≥1/2.
* Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group).
* Adequate organ function is needed, including cardio-respiratory, hepato-renal and hematological reserves: Absolute neutrophil count (ANC)≥1.5×109/L;Platelet count≥100×109/L; ASAT\&ALST\<1.5 times upper limit of normal (ULN) (With hepatic metastases, ASAT\&ALST\<5.0 times upper limit of normal);Bilirubin \<1.5 times ULN;Creatinine≤1.25×ULN or Creatinine clearance≥50 mL/min.
* Signed written informed consent prior to study entry.
Exclusion Criteria:
* Previous radiation or chemotherapy treatment or major pelvic surgery.
* Patients with distant metastasis confirmed by imaging or pathology.
* Other uncured malignant tumors in the past five years, except the cured skin basal cell carcinoma and breast carcinoma in situ.
* Any prior anticancer therapy.
* Unable to tolerate postoperative concurrent chemoradiotherapy.
* Patients with evidence of being allergic to fluorouracil, cisplatin or Endostar.
* Patients with serious comorbidity that might potentially influence the practice of protocol, including severe infection, myocardial infarction, severe arrhythmia, severe cerebrovascular disease, severe mental disorder, etc.
* Patients with Heart related adverse events or thrombotic events in the past 6 months.
* Patients with hepatitis B, hepatitis C and human immunodeficiency virus (HIV) or any other active viral infections.
* Participate in other clinical researchers.
* The estimated survival\<3 months;
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03622827
Study Brief:
Protocol Section:
NCT03622827