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

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

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).

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.

Inclusion Criteria:

1. Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
2. No previous history of radiotherapy and surgery of brain
3. Agree to radiotherapy
4. age > 18 and <75 years
5. ECOG performance status 1 or less
6. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
7. Have provided informed consent

Exclusion Criteria:

1. Seizure cannot be controled by the drugs
2. Combined with other disease of the brain such as tumour or infarction
3. Hypersensitivity to MR enhancer