NCT00057746

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy. PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).

Detailed description

OBJECTIVES: * Compare the incidence of chronic neurotoxicity in patients treated with these regimens. * Compare quality of life of patients treated with these regimens. (phase III closed to accrual as of 12/31/05) OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity. * Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity. * Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity. Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years. Patients are followed every 6 months for 1 year and then annually for 3 years. PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Prophylactic cranial irradiation, 2.5 Gy fx	Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy
RADIATION	Prophylactic cranial irradiation, 2.0 Gy fx	Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy
RADIATION	Prophylactic cranial irradiation, 1.5 Gy fx	Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy

Timeline

• Start date: 2003-02-01
• Primary completion: 2009-05-01
• Completion: 2013-11-01
• First posted: 2003-04-09
• Last updated: 2016-05-25
• Results posted: 2016-05-25

Locations

222 sites across 2 countries: United States, Canada