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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT03371550
Eligibility Criteria:
Inclusion Criteria:
* histologically or cytologically confirmed NSCLC,
* stage IIIB (excluding malignant pleural or pericardial effusions, tumoral volume exceeding one radiation field,
* N3 supraclavicular, and contralateral hilar nodal involvement) or inoperable stage IIIA defined by the new International Staging System \[21\],
* 18 ≤ age ≤ 75 years,
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2,
* weight loss \<10%,
* at least one measurable lesion according to RECIST 1.0 criteria,
* adequate hematopoietic function (absolute neutrophil count ≥2 × 109/l, platelets ≥100 × 109/l, and hemoglobin level ≥10g/dl), adequate hepatic function \[total serum bilirubin less than or equal to the institutional upper limit of normal (ULN), aspartate aminotransferase ≤1.5× ULN, and alkaline phosphatase ≤5× ULN\], and adequate renal function (serum creatinine ≤1.5× ULN).
Exclusion Criteria:
* patients previously treated with radiotherapy or chemotherapy for NSCLC,
* previous cancer except basocellular carcinoma and in situ carcinoma of the cervix curatively treated and other cancers curatively treated for at least 5 years,
* peripheral neuropathy NCI-CTC grade ≥2,
* noncontroled severe disease,
* pregnant or breast-feeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03371550
Study Brief:
Protocol Section:
NCT03371550