Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:Temozolomide and Capecitabine
Sponsors
Oncology Department II, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the trial and signed informed consent; 2. Aged = 18 years old; 3. Recurrence or refractory small cell lung cancer confirmed by histology or cytology; 4. MGMT methylation positive by PCR; 5. ECOG: 0-1 with life expectation of no less than 12 week; 6. 14 days before the laboratory need to meet: 1) ANC = 1.5 x 10^9/L; 2) Platelets = 100 x10^9/L; 3) Hb = 90 g/L (9 g/dL); 4) AST, ALT = 2.5 times the upper limit of normal (ULN); 5) Creatinine = 1.5 times the upper limit of normal (ULN) 6) Total bilirubin = 1.5 times the upper limit of normal (ULN); 7) Urine pregnancy test negative (women of childbearing age), and during the test to 3 months after the end of the test to take contraceptive measures; 7. Can be followed up regularly. ;Inclusion criteria: 1. Volunteer to participate in the trial and signed informed consent; 2. Aged = 18 years old; 3. Recurrence or refractory small cell lung cancer confirmed by histology or cytology; 4. MGMT methylation positive by PCR; 5. ECOG: 0-1 with life expectation of no less than 12 week; 6. 14 days before the laboratory need to meet: 1) ANC = 1.5 x 10^9/L; 2) Platelets = 100 x10^9/L; 3) Hb = 90 g/L (9 g/dL); 4) AST, ALT = 2.5 times the upper limit of normal (ULN); 5) Creatinine = 1.5 times the upper limit of normal (ULN) 6) Total bilirubin = 1.5 times the upper limit of normal (ULN); 7) Urine pregnancy test negative (women of childbearing age), and during the test to 3 months after the end of the test to take contraceptive measures; 7. Can be followed up regularly.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; or fertility but refused to take contraceptive measures; 2. Serious infection requiring antibiotics intervention during recruitment. 3. Allergic to test drugs; 4. Uncontrolled brain metastasis or mental illness; 5. Congestive heart failure, uncontrolled cardiac arrhythmia,6 months of myocardial infarction, unstable angina, stroke or transient ischemic attack; 6. Other malignancy within 5 years. except for the full treatment of cervical carcinoma in situ or skin squamous cell carcinoma, or has been the basic control of the skin basal cell carcinoma; 7. Can't be followed up or obey protocol; 8. Ineligible by the discretion of the investigator.;Exclusion criteria: 1. Pregnant or lactating women; or fertility but refused to take contraceptive measures; 2. Serious infection requiring antibiotics intervention during recruitment. 3. Allergic to test drugs; 4. Uncontrolled brain metastasis or mental illness; 5. Congestive heart failure, uncontrolled cardiac arrhythmia,6 months of myocardial infarction, unstable angina, stroke or transient ischemic attack; 6. Other malignancy within 5 years. except for the full treatment of cervical carcinoma in situ or skin squamous cell carcinoma, or has been the basic control of the skin basal cell carcinoma; 7. Can't be followed up or obey protocol; 8. Ineligible by the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effective rate;Disease progression free survival;;effective rate;Disease progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| tumor markers: CEA, NSE;Clinical symptoms;Tolerance;MGMT methylation;Overall survival time;;tumor markers: CEA, NSE;Clinical symptoms;Tolerance;MGMT methylation;Overall survival time; | — |
Countries
China
Contacts
Public ContactWu Jianyu;Wu Jianyu ;
Chinese PLA Genaral Hospital ;Chinese PLA Genaral Hospital
Outcome results
None listed