- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03135977
Apatinib and Etoposide as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy
December 5, 2017 updated by: xionghong cai, Sichuan Cancer Hospital and Research Institute
A Clincal Trial of Apatinib Mesylate and Etoposide(VP-16) as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low.
There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line treatment for advanced gastric cancer.
Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance.
However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 2
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: Xionghong Cai, Doctor
- Phone Number: 8618036672884
- Email: xionghong_cai@hotmail.com
Study Locations
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Sichuan
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Chendu, Sichuan, China, 610000
- Recruiting
- Sicchuan cancer hospital
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Contact:
- xiaohong Cai, Doctor
- Phone Number: 8618036672884
- Email: xionghong_cai@hotmail.com
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-
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:
- Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy
- Performance status of 0~2 on the ECOG criteria
- Expected survival is above three months
- Adequate hematologic (neutrophil count>=1.5×109/L, hemoglobin>=80g/L, platelets>=80×109/L), hepatic function (aspartate transaminase (AST) & alanine transaminase(ALT) =<upper normal limit(UNL) x2, bilirubin level =< UNL x 1.5)
- Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.
Exclusion Criteria:
- suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
- Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
- Bleeding tendency or coagulation disorders.
- Uncontrolled hypertension (systolic pressure>150 mmHg , or diastolic pressure> 90 mmHg).
- Urine protein≥++, or urine protein in 24 hours≥2.0g.
- severe uncured wounds, ulcers or fracture.
- Pregnant or breast-feeding.
- Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
- The researcher believe that the Patient is not suitable to participate in the study.
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: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Apatinib, Etoposide
Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .
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Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 6 months
|
The first day of treatment to the date that disease progression is reported
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: up to 24 months
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the first day of treatment to death or last survival confirm date
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up to 24 months
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Duration of Response
Time Frame: up to 24 months
|
Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse
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up to 24 months
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Tumor response rate
Time Frame: Time Frame: 3 month
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The ratio between the number of responders and number of patients assessable for tumor response.
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Time Frame: 3 month
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Quality of Life (QoL) questionnaire
Time Frame: up to 24 months
|
in cancer patients and survivors with dermatologic conditions.
This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis.
Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s.
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up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xionghong Cai, Doctor, Sichuan Cancer Hospital and Research Institute
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)
December 1, 2018
Study Completion (ANTICIPATED)
December 1, 2018
Study Registration Dates
First Submitted
April 27, 2017
First Submitted That Met QC Criteria
April 27, 2017
First Posted (ACTUAL)
May 2, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 7, 2017
Last Update Submitted That Met QC Criteria
December 5, 2017
Last Verified
December 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
- Apatinib
Other Study ID Numbers
- Ahead-SL-20170220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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