Trial Information

CALGB 30610

Phase III comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Eligibility Criteria:

Histologically or cytologically documented small cell lung cancer
Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes.
Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible.
Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible.
Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray, are not eligible.
Measurable Disease Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 2 cm with conventional techniques or as = 1 cm with spiral CT scan.
Prior Treatment
No prior radiotherapy or chemotherapy for SCLC
No prior mediastinal or thoracic radiotherapy
Patients with complete surgical resection of disease are not eligible
Age greater than or equal to 18 years of age
ECOG Performance Status 0-2
No patients that are known to be pregnant or nursing.
Required Initial Laboratory Values

Granulocytes greater than or equal to 1,500/µl
Platelet Count greater than or equal to 100,000/µl
Total Bilirubin less than or equal to 1.5 x ULN
AST (SGOT) less than or equal to 2.0 x ULN
Serum Creatinine
OR
Calculated Creatinine Clearance
less than or equal to 1.5 x ULN
greater than or equal to 70 ml/min

Holy Cross Hospital
4725 N. Federal Hwy.
Fort Lauderdale, FL 33308
Phone: 954-267-7750

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Research Center Information: Holy Cross Hospital

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