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

Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

PURPOSE: This randomized phase II/III trial is studying how well brain irradiation works and compares three different brain irradiation regimens in preventing brain metastases in patients with limited-stage small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

• Compare the incidence of brain metastases in patients with limited stage small cell lung cancer treated with different regimens of prophylactic cranial irradiation. (phase III closed to accrual as of 12/31/05)

• Compare the overall and disease-free survival of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)

• Compare the incidence of chronic neurotoxicity in patients treated with these regimens.

• Compare quality of life and late treatment sequelae 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

• NCT number: NCT00057746
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2003
• Completion date: November 2013