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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT00349492
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically diagnosed small cell lung cancer
* Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion)
* If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
* No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy)
* One or more measurable disease by RECIST criteria
* at least 18 years of age
* Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria
* Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL) function
* Informed consent from patient which conforms to Institutional Review Board
Exclusion Criteria:
* History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years
* Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
* Uncontrolled serious infection
* Enrollment in other study within 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00349492
Study Brief:
Protocol Section:
NCT00349492