Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC — NVALT11  

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

Official title: Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.

Status Completed

Clinical Trial Summary

For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.

Clinical Trial Description

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 intention. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)
• Radical Treatment
• Stage III Non-Small Cell Lung Cancer

• NCT number: NCT01282437
• Study type: Interventional
• Source: Maastricht Radiation Oncology
• Status: Completed
• Phase: Phase 3
• Start date: January 2009
• Completion date: March 2015