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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT00524706
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent.
* Adequate oral intake.
* Histologically proved adenocarcinoma (colorectal cancer).
* Unresectable, recurrent and advanced colorectal cancer.
* At least 4 weeks since prior major surgery
* Age: 20 - 74 at enrollment.
* Performance Status (Eastern Cooperative Oncology Group \[ECOG\] scale): 0 - 2.
* No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
* Proved presence of measurable lesions within 30 days before enrollment.
* Patients with the following function of bone marrow, liver and kidney based on the laboratory values measured within 15 days before enrollment.
* Hemoglobin \>\_ 9.0g/dL
* WBC: LLN - 12,000/mm3
* Absolute granulocyte count \>\_ 1,500/mm3
* Platelets \>\_ 100,000/mm3
* Total Bilirubin \<\_ 1.5mg/dL
* AST(GOT) and ALT(GPT) \<\_ 100U/L
* ALP \<\_ 600U/L
* Creatinine \<\_ 1.0mg/dl
* Expected to survive more than 90 days after enrollment.
Exclusion Criteria:
* Patients who not received S-1 and Oxaliplatin as neoadjuvant or adjuvant chemotherapies before enrollment.
* Contraindication to S-1, and serious hypersensitivity to oral Leucovorin.
* No other concurrent investigational therapy.
* Patients did who not received blood transfusion and hematogenesis stimulating agents (ex. Granulocyte-Colony Stimulating Factor).
* Serious drug hypersensitivity.
* Prior history of peripheral neuropathy.
* Marked infection or inflammation (ex. patients with a fever of 38.0 degrees or higher).
* Poorly-controlled diabetes, hypertension or hypercalcemia.
* Severe (inpatient care is needed) arrhythmia, heart disease or its history.
* Severe (inpatient care is needed) lung disease (ex. interstitial pneumonia or pulmonary fibrosis).
* Psychiatric disorder requiring to receive treatment with antipsychotic drug.
* Fresh bleeding from the gastrointestinal tract.
* Requiring to drainage massive ascites, pleural effusion retention or pericardial fluid.
* Extensive bone metastasis.
* Clinically suspicious brain metastasis or brain metastasis.
* Diarrhea (watery diarrhea).
* Simultaneously active double cancer.
* Pregnancy or nursing female patients and possibility (intent) to bear baby. Male patients with intent to impregnate.
* Other patients evaluated to be inadequate to participate in the study by (sub) investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
74 Years
Study:
NCT00524706
Study Brief:
Protocol Section:
NCT00524706