Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
NCT ID: NCT01158170
Last Updated: 2010-07-08
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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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2010-06-30
2013-12-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer
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Detailed Description
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Primary
Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
Secondary
Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.
Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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prophylactic cranial irradiation
Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions.
Prophylactic cranial irradiation
25GY/10fraction
Erlotinib /Gefitinib
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Conctrol
Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity
Erlotinib /Gefitinib
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Interventions
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Prophylactic cranial irradiation
25GY/10fraction
Erlotinib /Gefitinib
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
3. No previous history of radiotherapy and surgery of brain
4. good response( CR/PR) to Erlotinib or Gefitinib.
5. Agree to radiotherapy
6. age \> 18 and \<75 years,ECOG performance status 1 or less
7. Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB\>=80g /DL) functions
8. 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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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Zhejiang Cancer Hospital
Principal Investigators
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Shenglin Ma, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZhejiangCH06
Identifier Type: -
Identifier Source: org_study_id
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