Study Title

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin or Carboplatin and Etoposide

Summary

The purpose of this study is to compare the effects, good and/or bad, of two different ways to give radiation therapy. One of the ways is experimental, while one of them is standard. The experimental way of giving the radiation therapy is once a day with a high dose of radiation for 7 weeks. The standard way of giving the radiation therapy is to give it twice a day for 3 weeks.

Objective

Primary Objective: To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3 weeks) in patients with limited stage small cell lung cancer. Secondary Objectives 1 To compare treatment related toxic effects of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer. 2 To compare response rates, failure-free survival and toxicity of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer. 3 To compare rates of local relapse, distant metastases and brain metastases with these regimens. 4 To compare patients quality of life between these treatment regimens in terms of their physical symptoms, physical functioning and psychological state. 5 To describe the patterns of use of thoracic intensity modulated radiation therapy (IMRT) in patients with limited stage small cell lung cancer. 6 To examine blood-based biomarkers of response and resistance to cisplatin (or carboplatin) and etoposide. 7 To evaluate the correspondence between increases in plasma ProGRP concentrations and disease progression/recurrence. 8 To evaluate the potential for plasma ProGRP concentrations at baseline, after each cycle of chemotherapy and at first evaluation following completion of chemotherapy to predict PFS and OS. 9 To evaluate the correspondence between longitudinal decreases in plasma ProGRP concentrations and clinical response.