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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT03601156
Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic diagnosis of rectal cancer, Stage IV.
* Males or females between 18 Years to 75 Years.
* No prior cisplatin-based chemotherapy or radiotherapy.
* Performance status of 0～2 on the ECOG criteria.
* Adequate hematologic (Leukocyte count \>= 4,000/uL, neutrophil count \>= 1,500/uL, hemoglobin \>= 10 g/dL, platelets \>= 100,000/uL), hepatic (AST \& ALT =\< upper normal limit(UNL)x1.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL x1.5 or creatinine clearance rate ≥60 ml/min) function.
* Patient can take oral medicine
* Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
Exclusion Criteria:
* Patient with allergic to S-1 or ingredient of Oxaliplatin
* Patient with Peripheral neuropathy
* Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days.
* Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes.
* Enrollment in other study.
* Pregnant or breast-feeding.
* Seriously psyche or intelligence problem.
* Inability to comply with protocol or study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03601156
Study Brief:
Protocol Section:
NCT03601156