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Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring tumors metastatic to brain, non-small cell lung cancer, Icotinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cytologic or histological diagnosis of non-small cell lung cancer
  • Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated
  • Patients are diagnosed with multiple brain metastases for the first time in 4 weeks
  • Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).
  • Doctors consider the patient will benefit from WBRT
  • No prior brain radiotherapy
  • ECOG performance status 0-2
  • age:18-75 years
  • Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L
  • Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement)
  • Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
  • Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study

Exclusion Criteria:

  • Prior brain radiation therapy
  • Solitary brain metastasis according to Magnetic resonance imaging (MRI)
  • Mort than 3 extracranial organs have metastatic lesions
  • Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
  • pregnant or breast feeding women

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib plus Whole Brain Radiotherapy

Arm Description

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM). Icotinib is a new first generation EGFR-TKI. We conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with whole brain radiotherapy （WBRT） in Chinese NSCLC patients with BM and investigated the cerebrospinal fluid (CSF)/ plasma concentrations of icotinib.

Outcomes

Primary Outcome Measures

partial response rate of intracranial lesions
Partial response rate of intracranial lesions will be measured.

Secondary Outcome Measures

Progression-free survival
Progression-free survival will be evaluated
overall survival
Overall survival will be evaluated
partial response rate of extracranial lesions
Partial response rate of extracranial lesions will be evaluated
Health-related quality of life
Health-related quality of life will be measured
safety and tolerability
Safety and tolerability of Icotinib and whole brain radiotherapy will be monitored by evaluation of frequency,severity,and duration of treatment-emergent adverse events in all subjects
the relationship between Progression-Free Survival and EGFR mutation status
The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.

Full Information

First Posted
January 17, 2012
Last Updated
July 22, 2014
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01514877
Brief Title
Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
Official Title
Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.
Detailed Description
Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Cancer
Keywords
tumors metastatic to brain, non-small cell lung cancer, Icotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Icotinib plus Whole Brain Radiotherapy
Arm Type
Experimental
Arm Description
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM). Icotinib is a new first generation EGFR-TKI. We conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with whole brain radiotherapy （WBRT） in Chinese NSCLC patients with BM and investigated the cerebrospinal fluid (CSF)/ plasma concentrations of icotinib.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Intervention Description
Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.
Primary Outcome Measure Information:
Title
partial response rate of intracranial lesions
Description
Partial response rate of intracranial lesions will be measured.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival will be evaluated
Time Frame
4 years
Title
overall survival
Description
Overall survival will be evaluated
Time Frame
4 years
Title
partial response rate of extracranial lesions
Description
Partial response rate of extracranial lesions will be evaluated
Time Frame
2 years
Title
Health-related quality of life
Description
Health-related quality of life will be measured
Time Frame
2 years
Title
safety and tolerability
Description
Safety and tolerability of Icotinib and whole brain radiotherapy will be monitored by evaluation of frequency,severity,and duration of treatment-emergent adverse events in all subjects
Time Frame
4 year
Title
the relationship between Progression-Free Survival and EGFR mutation status
Description
The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.
Time Frame
4 years

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: Cytologic or histological diagnosis of non-small cell lung cancer Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated Patients are diagnosed with multiple brain metastases for the first time in 4 weeks Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI). Doctors consider the patient will benefit from WBRT No prior brain radiotherapy ECOG performance status 0-2 age:18-75 years Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement) Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Patients must sign an informed consent indicating that they are aware of the investigational nature of the study Exclusion Criteria: Prior brain radiation therapy Solitary brain metastasis according to Magnetic resonance imaging (MRI) Mort than 3 extracranial organs have metastatic lesions Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible). pregnant or breast feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Fan, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26148750
Citation
Fan Y, Huang Z, Fang L, Miao L, Gong L, Yu H, Yang H, Lei T, Mao W. A phase II study of icotinib and whole-brain radiotherapy in Chinese patients with brain metastases from non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Sep;76(3):517-23. doi: 10.1007/s00280-015-2760-5. Epub 2015 Jul 7.
Results Reference
derived

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Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer

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