Radiation Therapy in Treating Patients With Extensive Stage Small Cell

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01055197
Study type	Interventional
Source	Radiation Therapy Oncology Group
Contact
Status	Completed
Phase	Phase 2
Start date	March 2010
Completion date	December 2016

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms