- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03100955
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer
March 29, 2017 updated by: medley nie, Qingdao University
To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: keke nie, MD
- Phone Number: (86)18561857907
- Email: niekekeqd@163.com
Study Contact Backup
- Name: youxin ji, MD, Ph. D
- Phone Number: (86)532-68665078
- Email: ji6677@gmail.com
Study Locations
-
-
Shandong
-
Qingdao, Shandong, China, 266001
- Recruiting
- Affiliated Hospital of Qingdao University
-
Contact:
- Zhuang Yu, MD
- Phone Number: (86)18661805688
- Email: yuzhuang2002@163.com
-
Principal Investigator:
- Zhuang Yu, MD, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival
Time Frame: 24 months
|
from the date of randomization to disease progression
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Zhuang Yu, MD, Ph. D, The Affiliated Hospital of Qingdao University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Anticipated)
February 1, 2019
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
March 26, 2017
First Submitted That Met QC Criteria
March 29, 2017
First Posted (Actual)
April 4, 2017
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
March 29, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Etoposide
- Etoposide phosphate
- Cisplatin
- Apatinib
Other Study ID Numbers
- QU20170327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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