Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

  • End date
    Dec 23, 2021
  • participants needed
  • sponsor
    Guangzhou Medical University
Updated on 23 January 2021


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.


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.

Condition Small Cell Lung Cancer, Metastatic Carcinoma, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment Temozolomide, prophylaxis cranial radiotherapy
Clinical Study IdentifierNCT02605811
SponsorGuangzhou Medical University
Last Modified on23 January 2021


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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Metastatic Carcinoma or sclc or Small Cell Lung Cancer or small cell carcinoma of the lung or small cell carcinoma?
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
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