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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT04798820
Eligibility Criteria:
Inclusion Criteria:
* histologically proven primary gastric adenocarcinoma,
* T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging
* location of primary tumor; antrum, or angle, , lower body or mid body of the stomach
* No evidence of other distant metastasis,
* age ≥ 20 year old, ≤ 75 year old
* no prior or posterior treatment of chemotherapy or radiation therapy against any other malignancies
* adequate organ functions defined as indicated below:
1. WBC count: 3000/mm3 \~12,000/mm3,
2. \> serum Hemoglobin 8.0 g/dL
3. \> serum Platelet 100 000/mm3,
4. \< serum AST 100 IU/L,
5. \<serum ALT 100 IU/L,
6. \< Total Bilirubin 2.0 mg/dL,
* written signed informed consent
Exclusion Criteria:
* active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer),
* gastric remnant cancer
* ≥T3, T4 in surgical staging before resection
* N2 or more (number of metastatic lymph nodes ≥3) in CT scan
* histologically rare variants in World Health Organization (WHO) Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others
* pregnant or breast-feeding women,
* mental disorder(diagnosed with mental disorder on medical record),
* unstable angina or myocardial infarction within 6 months of the trial,
* unstable hypertension,
* diabetes mellitus on insulin,
* severe respiratory disease requiring continuous oxygen therapy,
* previous upper abdominal surgery except laparoscopic cholecystectomy,
* surgical complication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT04798820
Study Brief:
Protocol Section:
NCT04798820