Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases (TRACTS)
Primary Purpose
Non-small-cell Lung Cancer, Brain Metastases
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Erlotinib
concurrent brain radiotherapy
secondary brain radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring Erlotinib, brain radiotherapy, NSCLC, brain metastases
Eligibility Criteria
Inclusion Criteria:
- Over the age of 18 years old;
- Tissue or cell pathological diagnosis of NSCLC;
- Brain CT or MR validated BM;
- Non-increased-intracranial-pressure symptomatic BM;
- Haven't received TKI target treatment;
- Haven't received brain radiotherapy;
- Patients in initial treatment should be detected EGFR mutation;
- Expected survival more than 6 months;
- KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain metastases;
- Liver and kidney function requirements: SGOT/SGPT≦2.5 times of the upper limit, Total bilirubin≦1.5 times of the upper limit, serum Creatinine≦1.5 times of the upper limit;
- Routine blood test requirements: WBC≧3.0×109/L, NE≧1.8×109/L, PLT≧90×109/L,no requirement for Hb;
- Blood glucose requirements: within the normal range, diabetic patients are receiving treatment and their glucose was being controlled in a steady state;
- Female patients in childbearing age: HCG (-);
- Patients signed an inform Consent.
Exclusion Criteria:
- Those with Erlotinib drug allergies;
- Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
- Those without guardians or families;
- Those with abnormal routine blood test, liver and kidney function, and blood glucose beyond the above boundaries and difficult to correcting for more than 2 weeks;
- Those with any unstable medical status (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction (within one year before treatment initiation), and severe arrhythmia, liver, kidney or metabolic disease requiring drug therapy);
- Those with any other disease, neurological or metabolic dysfunction, and physical examination or laboratory test results showed that the study drugs may increase the risk of treatment-related complications;
- Pregnant women.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Erlotinib & secondary brain radiotherapy
Erlotinib & concurrent brain radiotherapy
Arm Description
Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.
Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT01763385
First Posted
January 4, 2013
Last Updated
December 22, 2014
Sponsor
Wu Jieping Medical Foundation
Collaborators
Fudan University, Changhai Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Longhua Hospital, RenJi Hospital, Shanghai Armed Police Hospital, Shanghai Chest Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01763385
Brief Title
Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases
Acronym
TRACTS
Official Title
Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases: A Prospective Multicenter Trial(TRACTS)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wu Jieping Medical Foundation
Collaborators
Fudan University, Changhai Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Longhua Hospital, RenJi Hospital, Shanghai Armed Police Hospital, Shanghai Chest Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Control group are Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer, Brain Metastases
Keywords
Erlotinib, brain radiotherapy, NSCLC, brain metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib & secondary brain radiotherapy
Arm Type
Experimental
Arm Description
Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.
Arm Title
Erlotinib & concurrent brain radiotherapy
Arm Type
Other
Arm Description
Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Type
Radiation
Intervention Name(s)
concurrent brain radiotherapy
Intervention Type
Radiation
Intervention Name(s)
secondary brain radiotherapy
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3.5year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over the age of 18 years old;
Tissue or cell pathological diagnosis of NSCLC;
Brain CT or MR validated BM;
Non-increased-intracranial-pressure symptomatic BM;
Haven't received TKI target treatment;
Haven't received brain radiotherapy;
Patients in initial treatment should be detected EGFR mutation;
Expected survival more than 6 months;
KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain metastases;
Liver and kidney function requirements: SGOT/SGPT≦2.5 times of the upper limit, Total bilirubin≦1.5 times of the upper limit, serum Creatinine≦1.5 times of the upper limit;
Routine blood test requirements: WBC≧3.0×109/L, NE≧1.8×109/L, PLT≧90×109/L,no requirement for Hb;
Blood glucose requirements: within the normal range, diabetic patients are receiving treatment and their glucose was being controlled in a steady state;
Female patients in childbearing age: HCG (-);
Patients signed an inform Consent.
Exclusion Criteria:
Those with Erlotinib drug allergies;
Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
Those without guardians or families;
Those with abnormal routine blood test, liver and kidney function, and blood glucose beyond the above boundaries and difficult to correcting for more than 2 weeks;
Those with any unstable medical status (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction (within one year before treatment initiation), and severe arrhythmia, liver, kidney or metabolic disease requiring drug therapy);
Those with any other disease, neurological or metabolic dysfunction, and physical examination or laboratory test results showed that the study drugs may increase the risk of treatment-related complications;
Pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huanjun Yang, Master
Phone
+86-21-64175590
Ext
6723
Email
yanghj_1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huanjun Yang
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huanjun Yang, Master
Phone
+86-21-64175590
Ext
6723
Email
yanghj_1@hotmail.com
12. IPD Sharing Statement
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Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases
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