Back to resultsIcotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases
Primary Purpose
Non-small-cell Lung Cancer
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Icotinib plus WBRT
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
- Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- No other metastases except for brain metastases.
Exclusion Criteria:
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Sites / Locations
- Baotou Central HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Icotinib plus WBRT
Arm Description
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day.
Outcomes
Primary Outcome Measures
Objective response rate of intracranial lesions
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Secondary Outcome Measures
Objective response rate of extracranial lesions
Number of participants with an objective response of extracranial lesions. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Progression-free survival of intracranial lesions
All cause progress or mortality
Safety and tolerability
All cause adverse events (AEs) and serious adverse events (SAEs)
Full Information
NCT ID
NCT01926171
First Posted
August 16, 2013
Last Updated
July 14, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01926171
Brief Title
Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases
Official Title
A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.
Detailed Description
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib plus WBRT
Arm Type
Experimental
Arm Description
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day.
Intervention Type
Drug
Intervention Name(s)
Icotinib plus WBRT
Other Intervention Name(s)
Commana, BPI-2009
Intervention Description
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day.
Primary Outcome Measure Information:
Title
Objective response rate of intracranial lesions
Description
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Objective response rate of extracranial lesions
Description
Number of participants with an objective response of extracranial lesions. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Time Frame
8 weeks
Title
Progression-free survival of intracranial lesions
Description
All cause progress or mortality
Time Frame
3-6 months
Title
Safety and tolerability
Description
All cause adverse events (AEs) and serious adverse events (SAEs)
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
No other metastases except for brain metastases.
Exclusion Criteria:
Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhu, MD
Phone
86-18686111667
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhu, MD
Organizational Affiliation
Baotou Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhu, MD
First Name & Middle Initial & Last Name & Degree
Wei Zhu, MD
12. IPD Sharing Statement
Learn more about this trial
Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases
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