Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
For this group of patients, brain metastases are one of the major sites of tumor failure.
Radical therapy of symptomatic brain metastases is seldom possible and only very rarely,
long term survival can be achieved. PCI has shown to reduce the incidence of brain
metastases in patients with non-small cell lung cancer to the same extent as in limited
disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient,
treated with contemporary chemo-radiation schedule with or without surgery, remains
unsettled. Therefore this study is launched, in order to investigate whether PCI should
become the standard of care in patients with stage III NSCLC who are treated with curative
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients developing symptomatic brain metastasis
24 months after randomisation
Dirk De Ruysscher, MD, PhD
NVALT oncology foundation
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)