small cell lung cancer
Conditions
Interventions
limited stage SCLC:The first cycle CPT-11(Campto)+DDP accompanied with radiotherapy, then sequential chemotherapy
extend stage SCLC:CPT-11(Campto)+DDP chemotherapy +/- radiotherapy
Sponsors
Tongji Medical College, Hua Zhong University of Science & Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven SCLC; 2. Aged between 18 and 75, male or female; 3. Measurable disease, defined as to RECIST1.1criteria (conventional CT scan >= 20mm, spiral CT scan >= 10mm, no radiotherapy received for the measurable lesions). Lesions should be measured 2 weeks before randomization; 4. CPT-11+Cisplatin as the first-line therapy; 5. No previous CPT-11 chemotherapy; 6. ECOG performance status (PS) 0-2; 7. Not pregnant or nursing and Negative pregnancy test; 8. Voluntarily signed the informed consent; 9. Total bilirubin 50 mL/min OR serum creatinine <=1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Brain metastases with obvious symptoms; 2. Severe bone marrow failure and can not be corrected; 3. Chronic diarrhea history and the researchers believe that patients should not participate in the trial; 4. Bowel obstruction without control; 5. Mental illness without control; 6. Clinically significant (i.e., active cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension); 7. Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix; 8. Chest radiotherapy history; 9. Pelvic radiotherapy for the past 1 year; 10. Known allergy to any of the components of the study medications; 11. Serious, nonhealing wound or ulcer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;The incidence of Grade III and above diarrhea;The incidence of Grade II and above neutropenia and; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS; | — |
Countries
China
Contacts
Public ContactLi Liu
Outcome results
None listed