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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01839032
Eligibility Criteria:
Inclusion Criteria:
* histologically or cytologically confirmed stage IIIA (only N2),
* dry IIIB previously untreated inoperable NSCLC,
* 18 to 75 years old,
* Karnofsky Performance Status (KPS) ≥ 80%,
* weight loss ≤ 10% within the previous 3 months,
* normal organ functions were eligible.
* at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) \[10\].
Exclusion Criteria:
* stages I, II, IIIA (excepted N2), IIIB with pleural effucion and stage IV,
* pregnant or breastfeeding women. Women of Childbearing Age: Women of childbearing potential should take reliable contraceptive measures
* Symptomatic Neuropathy \> grade 1,
* associated Pathology and/or not controled diseases(cardiac insuficiency, myocardial infarction within 3 months before the inclusion ; hypertension, arythmia or uncontroled hypercalcémia; infection requiering iv antibiotic administration within 2 weeks before inculion),
* other associated cancer with the exception of cervical carcinoma in situ or skin cancer baso-cellular correctely treated,
* Previous treatment with an other antineoplasic,
* Known hypersensibility to drugs with a similar chemical structure ti this studied.
* important malabsorbtion syndrom or disease of gastro-intestinal track,
* Participation to another clinical trial within 30 days before inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01839032
Study Brief:
Protocol Section:
NCT01839032