Status:
TERMINATED
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
Lead Sponsor:
Yi-Long Wu
Conditions:
Brain Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Detailed 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 ch...
Eligibility Criteria
Inclusion
- 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
- No previous history of radiotherapy and surgery of brain
- Agree to radiotherapy
- age \> 18 and \<75 years
- ECOG performance status 1 or less
- Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions
- Have provided informed consent
Exclusion
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00745797
Start Date
April 1 2008
End Date
August 1 2012
Last Update
March 6 2017
Active Locations (1)
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1
Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080