Back to resultsA Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
Primary Purpose
Progression Free Survival
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
cisplatin, etoposide
cisplatin, etoposide, apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Progression Free Survival
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically verified SCLC, extensive stages
- WHO performance status 0, 1, 2
- Age 18 years or older
- Treatment naive
- Anticipated survival more than 3 months
- HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L
- No prognancy
- Signed informed consent
Exclusion Criteria:
- Limited stage disease
- Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
- Uncontrolled hypertension
- Uncontrolled heart failure
- Coagulation problem
- Surgery, trauma, uncontrolled ulcer in 4 weeks.
- Required by physician
Sites / Locations
- Affiliated Hospital of Qingdao UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EP chemotherapy
EP chemotherapy plus apatinib
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
progression free survival
from the date of randomization to disease progression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03100955
Brief Title
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
Official Title
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression Free Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EP chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EP chemotherapy plus apatinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin, etoposide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin, etoposide, apatinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression free survival
Description
from the date of randomization to disease progression
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically verified SCLC, extensive stages
WHO performance status 0, 1, 2
Age 18 years or older
Treatment naive
Anticipated survival more than 3 months
HB >90g/L, ANC>1.5 x 109/L, Platelets >80 x109 /L
No prognancy
Signed informed consent
Exclusion Criteria:
Limited stage disease
Metastastic meningitis, spinal compression, Tumor to main vesicular less than 5mm
Uncontrolled hypertension
Uncontrolled heart failure
Coagulation problem
Surgery, trauma, uncontrolled ulcer in 4 weeks.
Required by physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
keke nie, MD
Phone
(86)18561857907
Email
niekekeqd@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
youxin ji, MD, Ph. D
Phone
(86)532-68665078
Email
ji6677@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuang Yu, MD, Ph. D
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuang Yu, MD
Phone
(86)18661805688
Email
yuzhuang2002@163.com
First Name & Middle Initial & Last Name & Degree
Zhuang Yu, MD, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
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