small cell lung cancer
Conditions
Interventions
EL:Day 1-3: VP-16 100mg/m2/day
Day 1: lobaplatin 30mg/m2/day. Each therapy cycle consists of 21 days. Maximun: 6 cycles
EP:lobaplatin 30mg/m2/day. Each therapy cycle consis
Sponsors
Jilin province cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years old; male or female patients; 2. With the diagnosis of SCLC confirmed by pathological tests; 3. With massive metastasis (patients will be excluded if pleural effusion is the only presentation of metastasis); 4. No history of chemotherapy; 5. More than 14 days after palliative surgical interventions or radiotherapy for metastasis foci; 6. With measurable metastasis foci; 7. ECOG PS: 0-1; 8. Life expectancy >=3 months; 9. Laboratory parameters: Bone marrow function: ANC>=2.0*10^9/L; PLT>=100*10^9/L; HB>=95g/L; Hepatic function: STB and CB=60 ml/min (Cockcroft-Gault); Coagulation function: PT INR<=ULN*1.5; 10. Female: postmenopausal period or have received sterilization operation, or contraception during treatment and within 6 months after the therapy; non-breast feeding period; Male: have received sterilization operation, or contraception during treatment and within 6 months after the therapy; 11. Voluntary to participate and sign informed consent document.
Exclusion criteria
Exclusion criteria: 1. Allergic to drugs used in the trial; 2. Active peptic ulcer; 3. Have received surgical intervention or ratiotherapy for primacy foci; 4. Have received drugs (including Chinese Medcine) with anti-lung cancer properties approved by SFDA; 5. Interstitial pneumonia or lung fibrosis confirmed by image tests; 6. Active brain metastasis that requires therapy; 7. Narrowing of main bronchi or lobe bronchi and superior vena cava syndrome caused by tumor compression; uncontrolled moderate to severe pleural, pericardial effusion and ascites; 8. Severe infection, SIADH and uncontrolled diabetes; with severe complications requiring therapy, such as superior vena cava syndrome; 9. Severe cardiaovascular diseases including uncontrolled hypertension, unstable angina pectoris, cardiac infarction, heart failure (>3 according to NYHA standard) and severe cardiac arrhythmia; 10. History of hemorrhage (>=CTCAE 3) within the latest 4 weeks; 11. Patients needing anticoagulation therapy or vitamin K antagonists (excluding prevention use of small dosage of warfarin<=1mg/d and aspirin<=100mg/d); 12. Have participated in other drug trial within the latest 4 weeks or quit after the randomization allocation; 13. Severe infection that requires intravenous use of antibiotics, anti-fungal or anti-virus therapy; 14. With multiple primary cancers (excluding intraepithelial cancer and no relapse within 5 years); 15. Pregnant or breast-feeding women; or women planning to get pregnant; 16. Have participated in other drugs trials within 6 months before getting the informed consent documents; 17. Other patients that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression-free survival;Overall survival;Quality of life;Objective response rate; | — |
Countries
China
Contacts
Public ContactDonghu Sui
Outcome results
None listed