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 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT00401492
Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic diagnosis of NSCLC
* Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
* Age \> o = 70 years.
* Written informed consent.
Exclusion Criteria:
* Performance status (ECOG) ³2
* Previous chemotherapy.
* Symptomatic brain metastases requiring synchronous radiotherapy
* Previous radiotherapy (completed less than 4 weeks before enrollment)
* Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
* Neutrophils \< 2.000/mm³ or platelets \< 100.000/mm³ or hemoglobin \< 10 g/dl.
* Serum creatinine \> 1.5 times the UNL.
* GOT and/or GPT \>1.25 times the UNL or serum total bilirubin \>1.25 times the UNL without hepatic metastases.
* GOT and/or GPT \>2.5 times the UNL or serum total bilirubin \>1.5 times the UNL with hepatic metastases.
* Other concomitant diseases contraindicating the study treatments.
* Refusal of written informed consent.
* Follow-up impossible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT00401492
Study Brief:
Protocol Section:
NCT00401492