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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00030433
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
* Malignant pleural effusion constitutes extensive stage disease
* Must have disease outside area of prior surgical resection or a new lesion must be present
* Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy)
* Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy for SCLC
Chemotherapy:
* No prior systemic chemotherapy for SCLC
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy for SCLC except for brain metastases
Surgery:
* See Disease Characteristics
* At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00030433
Study Brief:
Protocol Section:
NCT00030433