Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases
- Registration Number
- NCT02385136
- Lead Sponsor
- Zhejiang Cancer Hospital
- Brief Summary
The purpose of this study is to evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
- histologically diagnosed as NSCLC, stage IVb [ (American Joint of Cancer Committee(AJCC), 2002) ], Brain metastasis
- no history of hypertension or diabetes.
Exclusion Criteria
- the brain tumor diameter >5cm; RPA class =3; pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WBRT plus TMZ arm Temozolomide whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ)
- Primary Outcome Measures
Name Time Method Time to central nervous system progress which was confirmed by MRI 1 to 24 months post procedure objective response rate 1 month post procedure
- Secondary Outcome Measures
Name Time Method The Quality of Life 0 to 24 months post procedure Toxicity as measured by CTCAE V4.0 0 to 24 months post procedure Overall Survival 1 to 24 months post procedure