Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
NCT01158170 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2010-07-08
Summary
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
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
Conditions
Interventions
- RADIATION
-
Prophylactic cranial irradiation
25GY/10fraction
- DRUG
-
Erlotinib /Gefitinib
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
Sponsors & Collaborators
-
Zhejiang Cancer Hospital
lead OTHER
Principal Investigators
-
Shenglin Ma, MD · Zhejiang Cancer Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2013-05-31
- Completion
- 2013-12-31
Countries
- China
Study Locations
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