Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- temozolomide
- Conditions
- Small Cell Lung Cancer
- Sponsor
- Guangzhou Medical University
- Enrollment
- 426
- Locations
- 1
- Primary Endpoint
- 2-year incidence of brain metastases
- Last Updated
- 7 years ago
Overview
Brief Summary
To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.
Detailed Description
We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.
Investigators
Haihong Yang, MD, Pricipal investigator
Associate Chief Physician
Guangzhou Medical University
Eligibility Criteria
Inclusion Criteria
- •Histological or cytological diagnosis of small-cll lung cancer histology
- •18 years or older
- •Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- •Local stage SCLC without distant metastases
- •After 1st-line chemotherapy (EP or IP) at least 4 cycles
- •After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
- •CR or PR assessment by RECIST(1.0) before randomized
- •Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L
- •Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
- •Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Exclusion Criteria
- •Mixed non-small cell lung cancer histology
- •Neck and supraclavicular lymph node metastasis
- •Be allergic to temozolomide or intolerable to radiotherapy
- •Any unstable systemic disease
- •Pregnant or lactating women
Arms & Interventions
temozolomide
temozolomide oral 150mg/m2 d1-5/28d for 12 cycles
Intervention: temozolomide
prophylaxis cranial radiotherapy
prophylaxis cranial radiotherapy,25-30Gy/10Fra
Intervention: prophylaxis cranial radiotherapy
Outcomes
Primary Outcomes
2-year incidence of brain metastases
Time Frame: 2 year