Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide (CALGB-30610)

Documentation of Disease

1. Histologically or cytologically documented small cell lung cancer (SCLC)
2. 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 unless they have a negative thoracentesis
   • 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 ≥ 1 cm by spiral CT scan

Prior Treatment

1. Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide.
2. If a patient has had one cycle of cisplatin or carboplatin/etoposide prior to registration, the patient must have had all of it prior to registration tests as outlined in the protocol and prior to starting their first cycle of chemotherapy.
3. Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle of chemotherapy.
4. Registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy.
5. Failing to do all of the above will make the patient NOT eligible for CALGB 30610.
6. No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC
7. No prior mediastinal or thoracic radiotherapy
8. Patients with complete surgical resection of disease are not eligible

• Age Requirement ≥ 18 years of age
• ECOG Performance Status 0-2
• Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing

Required Initial Laboratory Values

1. Granulocytes ≥ 1,500/µl
2. Platelet count ≥ 100,000/µl
3. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
4. AST (SGOT) ≤ 2.0 times ULN
5. Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min

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Study Type

Phase III

Principal Investigator(s)

Patricia Griffin, M.D.

Sponsor(s)

 Alliance for Clinical Trials in Oncology