Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer

Conditions
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Small Cell Lung Cancer, Metastatic Carcinoma

Intervention / Treatment
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* Drug: temozolomide
* Radiation: prophylaxis cranial radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: temozolomide<br>temozolomide oral 150mg/m2 d1-5/28d for 12 cycles | Drug: temozolomide<br> <br> * Other names: Temozolomide Capsules;|
| Active Comparator: prophylaxis cranial radiotherapy<br>prophylaxis cranial radiotherapy,25-30Gy/10Fra | Radiation: prophylaxis cranial radiotherapy<br>* 2<br>* Other names: PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year incidence of brain metastases |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limited small cell lung cancer, brain metastases, prophylactic cranial radiotherapy, temozolomide