A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
NCT ID: NCT03100955
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2017-03-01
2019-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EP chemotherapy
Standard treatment or active comparator group 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=cisplatinum and etoposide.
cisplatin, 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.
EP chemotherapy plus apatinib
Apatinib treatment or experimental group contains standard chemotherapy and apatinib, a VEGF tyrosine kinase inhibitor. It contains a platinum drug, a topoisomerase inhibitor and a VEGF-TKI. 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=cisplatinum and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI=apatinib, 500 mg, oral daily after chemotherapy, until disease progression or death or un-tolerated toxicites. Used drugs=cisplatinum and etoposide and apatinib.
cisplatin, 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.
Interventions
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cisplatin, 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.
cisplatin, 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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Qingdao University
OTHER
Responsible Party
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medley nie
Secretary of clinical trials
Principal Investigators
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Zhuang Yu, MD, Ph. D
Role: STUDY_CHAIR
The Affiliated Hospital of Qingdao University
Locations
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Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QU20170327
Identifier Type: -
Identifier Source: org_study_id
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