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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT02114359
Eligibility Criteria:
Inclusion Criteria:
* .Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
* 70 yrs or older
* Eastern Cooperative Oncology Group 0-2
* Measurable or evaluable disease
* Adequate major organ functions
* Hb ≥ 9.0 g/dL
* White blood cell count ≥ 3000/μL
* Absolute Neutrophil Count (ANC) ≥ 1500/μL \[\*ANC = neutrophil segs ＋ neutrophil bands\]
* Platelet ≥ 100 × 103/ μL
* Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
* Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine \> 1.5 mg/dL , Ccr should be \>= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
* Life expectancy \> 3month
* Written informed consent
Exclusion Criteria:
* Metastatic or recurrent stomach cancer other than adenocarcinoma
* HER-2 positive
* Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
* Radiation therapy within the previous 2wks
* Major surgery or trauma within the previous 4wks
* Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
* Uncontrolled brain metastasis
* Presence of other serious disease (cardiovascular, hepatic, infection etc.)
* Patients who participated in other clinical trials within the previous 30days
* Men of childbearing potential not willing to use effective means of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02114359
Study Brief:
Protocol Section:
NCT02114359