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Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy — PCI  

Brain Metastases Clinical Trial

Official title:
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial

Clinical Trial Summary

1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.

2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .

3. The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).

Clinical Trial Description

1. Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .

2. PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.

3. But its impact on overall and disease free survival is uncertain. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00745797
Study type Interventional
Source Chinese Society of Lung Cancer
Contact
Status Terminated
Phase Phase 3
Start date April 2008
Completion date August 2012
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