Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
NCT ID: NCT00745797
Last Updated: 2017-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
5 participants
INTERVENTIONAL
2008-04-30
2012-08-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Prophylactic WBRT
Take the whole brain radiotherapy radiotherapy
Radiotherapy
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
Observer Group
The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale.
No interventions assigned to this group
Interventions
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Radiotherapy
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Combined with other disease of the brain such as tumour or infarction
3. Hypersensitivity to MR enhancer
18 Years
75 Years
ALL
No
Sponsors
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Yi-Long Wu
OTHER
Responsible Party
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Yi-Long Wu
Professor, director
Principal Investigators
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WU YI LONG, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Society of Lung Cancer
Locations
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Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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CSLC0801
Identifier Type: -
Identifier Source: org_study_id
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