Status:
COMPLETED
Dexamethasone and Supportive Care With or Without Whole-Brain Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer That Has Spread to the Brain and Cannot Be Removed By Surgery
Lead Sponsor:
Medical Research Council
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Steroid therapy, such as dexamethasone, may reduce swelling, pain, and other symptoms of inflammation and may be effective in treating some of the problems caused by cancer and cancer treat...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of dexamethasone with vs without whole-brain radiotherapy in combination with optimal supportive care, in terms of patient assessed quality adjusted life y...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary non-small cell lung cancer
- Must have brain metastases confirmed by CT scan or MRI
- Unresectable disease OR surgery is deemed inappropriate
- The benefit or lack of benefit of whole-brain radiotherapy (WBRT) cannot be clearly defined
- Any known certainty of the benefit or lack of benefit of WBRT is not allowed
- PATIENT CHARACTERISTICS:
- No prior or concurrent uncontrolled illness that could preclude study treatment or comparisons
- Must be able to respond to weekly telephone assessment questions
- PRIOR CONCURRENT THERAPY:
- More than 1 week since prior epidermal growth factor receptor inhibitors
- More than 1 month since prior chemotherapy
- More than 1 month since prior surgery for brain metastases
- No prior radiotherapy to the brain
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00403065
Start Date
October 1 2006
End Date
March 1 2013
Last Update
August 26 2013
Active Locations (70)
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1
Wansbeck General Hospital
Ashington, England, United Kingdom, NE63 9JJ
2
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
3
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
4
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ