Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 16, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 15, 2015
July 1, 2015
3.3 years
August 16, 2013
July 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (3)
Objective response rate of extracranial lesions
8 weeks
Progression-free survival of intracranial lesions
3-6 months
Safety and tolerability
6-12 months
Study Arms (1)
Icotinib plus WBRT
EXPERIMENTALStandard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day.
Interventions
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baotou Central Hospital
Baotou, Inner Mongolia, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Zhu, MD
Baotou Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2013
First Posted
August 20, 2013
Study Start
June 1, 2013
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
July 15, 2015
Record last verified: 2015-07