NCT01055197

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer. PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.

Detailed description

OBJECTIVES: Primary * To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy. Secondary * To compare treatment-related adverse events in these patients. * To evaluate patterns of failure in these patients. * To compare the time to first failure in these patients. * To evaluate the percentage of the planned radiotherapy dose given to each site. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks. * Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks. After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Prophylactic Cranial Irradiation	Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.
RADIATION	Radiation Therapy	Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-03-01
• Completion: 2016-12-01
• First posted: 2010-01-25
• Last updated: 2018-12-12
• Results posted: 2016-10-21

Locations

115 sites across 3 countries: United States, Canada, Israel