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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT01286766
Eligibility Criteria:
Inclusion Criteria:
* Histologically/cytologically confirmed gastric adenocarcinoma
* Age 18 to 70 years old
* ECOG performance Status 0\~1
* Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA\~IV), M0, P0, H0, CY0
* No pretreatment (radiotherapy or chemotherapy) for gastric cancer
* Adequate organ function
* Hb ≥ 9.0 g/dL
* WBC ≥ 4,000/µL
* ANC ≥ 2,000/µL (\*ANC = Neutrophil segs ＋ Neutrophil bands)
* Platelet ≥ 100 × 103/ µL
* Total bilirubin: ≤ 1.5 × UNL
* CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)
* AST/ALT, ALP: ≤ 2.5 × UNL
* Written informed consent
Exclusion Criteria:
* Distant metastasis on diagnosis
* cT1-2
* Cancer of gastroesophageal junction (GEJ)
* Poor oral intake or absorption deficiency syndrome
* Gastric outlet obstruction, perforation or bleeding
* Medically uncontrollable chronic illness or infection
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* History of clinically significant cardiac disease
* Past or concurrent history of neoplasm last \< 5 year other than gastric cancer
* Prior gastrectomized patients
* Concomitant administration of any other experimental drug under investigation
* Peripheral neuropathy ≥ NCI-CTC grade 2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01286766
Study Brief:
Protocol Section:
NCT01286766