Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

A regiszterben nem jelölt feltételek

• Documentation of Disease
  • Histologically or cytologically documented small cell lung cancer (SCLC)
  • 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
  • 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.
  • 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.
  • Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle of chemotherapy.
  • Registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy.
  • Failing to do all of the above will make the patient NOT eligible for CALGB 30610.
  • No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC
  • No prior mediastinal or thoracic radiotherapy
  • 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
  • Granulocytes ≥ 1,500/µl
  • Platelet count ≥ 100,000/µl
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST (SGOT) ≤ 2.0 times ULN
  • Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min