Progression Free Survival
Conditions
Brief summary
To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib
Detailed description
Assess progression free survival, overall survival and toxicity of standard EP regimen combined or not with VEGF tyrosine kinase inhibitor-apatinib. Response measured by RECIST response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.
Interventions
DRUGcisplatin, etoposide
The recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed.
DRUGcisplatin, etoposide, apatinib
Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites.
Sponsors
Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically verified SCLC, extensive stages 2. WHO performance status 0, 1, 2 3. Age 18 years or older 4. Treatment naive 5. Anticipated survival more than 3 months 6. HB \>90g/L, ANC\>1.5 x 109/L, Platelets \>80 x109 /L 7. No prognancy 8. Signed informed consent
Exclusion criteria
1. Limited stage disease 2. Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm 3. Uncontrolled hypertension 4. Uncontrolled heart failure 5. Coagulation problem 6. Surgery, trauma, uncontrolled ulcer in 4 weeks. 7. Required by physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 24 months | from the date of randomization to disease progression |
Countries
China
Contacts
Primary Contactkeke nie, MD
Backup Contactyouxin ji, MD, Ph. D
Outcome results
None listed