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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT00906061
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced NSCLC.
* Stage III with pleural effusion and stage IV.
* Patients with ECOG PS 2.
* Patients must have at least one measurable lesion, no previously irradiated.
* Life expectancy of at least 12 weeks.
* Adequate organ function according to the following criteria:
* Bone marrow: ANC =\> 2.0x10(9)cells/L; Platelet count =\> 100x10(9)cells/L; Hemoglobin =\> 10 g/dL.
* Liver function: Bilirubin \<= 1.5 X ULN; Alkaline phosphatase \<= 5 x ULN; AST and ALT \<= 1.5 x ULN.
* Renal function:serum creatinine \<= 2mg/dL.
Exclusion Criteria:
* Prior systemic chemotherapy for advanced disease.
* Prior radiotherapy for NSCLC.
* Patients with symptomatic brain metastases.
* No measurable bone metastases or malignant pleural effusion as only measurable lesion.
* History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
* History of hypersensitivity reaction study drugs.
* Pregnant or lactating women (women of childbearing potential must use adequate contraception).
* Concurrent treatment with other experimental drugs.
* Current peripheral neuropathy NCI grade 2.
* Participation in clinical trials within 30 days of study entry.
* Major surgery, open biopsy or traumatic lesion 28 days before to study start.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00906061
Study Brief:
Protocol Section:
NCT00906061