Lung Cancer Clinical Trial
Official title:
A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
known if giving radiation therapy to the head is effective in preventing CNS metastases in
patients who have stage III non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head
works in preventing CNS metastases in patients who have been previously treated for stage III
non-small cell lung cancer.
OBJECTIVES:
- Determine whether prophylactic cranial irradiation improves survival after effective
locoregional/systemic therapy in patients with stage IIIA or IIIB non-small cell lung
cancer.
- Determine the neuropsychologic impact of this therapy in these patients.
- Assess quality of life of patients receiving this therapy.
- Determine the impact of this therapy on the incidence of CNS metastases in these
patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (IIIA vs IIIB), histology (non-squamous cell vs squamous cell), and prior
surgery (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks.
- Arm II: Patients undergo observation.
Patients are followed 3 months during the first year, every 6 months for 2-3 years and then
annually thereafter. Quality of life is assessed at baseline and at months 6, 12, 24, 36, and
48.
PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for this
study within 36 months.
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