Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases (TRACTS)
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ClinicalTrials.gov Identifier: NCT01763385 |
Recruitment Status
: Unknown
Verified December 2014 by Yang Huan Jun, Fudan University.
Recruitment status was: Recruiting
First Posted
: January 8, 2013
Last Update Posted
: December 23, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small-cell Lung Cancer Brain Metastases | Drug: Erlotinib Radiation: concurrent brain radiotherapy Radiation: secondary brain radiotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | November 2012 |
Estimated Primary Completion Date : | May 2016 |
Estimated Study Completion Date : | May 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Erlotinib & secondary brain radiotherapy
Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.
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Drug: Erlotinib Radiation: secondary brain radiotherapy |
Erlotinib & concurrent brain radiotherapy
Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons
|
Drug: Erlotinib Radiation: concurrent brain radiotherapy |
- overall survival [ Time Frame: 3.5year ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763385
Contact: Huanjun Yang, Master | +86-21-64175590 ext 6723 | yanghj_1@hotmail.com |
China | |
Fudan University Shanghai Cancer Center | Recruiting |
Shanghai, China, 200032 | |
Contact: Huanjun Yang, Master +86-21-64175590 ext 6723 yanghj_1@hotmail.com |
Principal Investigator: | Huanjun Yang | Fudan University |
Responsible Party: | Yang Huan Jun, Fudan University |
ClinicalTrials.gov Identifier: | NCT01763385 History of Changes |
Other Study ID Numbers: |
2012-75-634 |
First Posted: | January 8, 2013 Key Record Dates |
Last Update Posted: | December 23, 2014 |
Last Verified: | December 2014 |
Keywords provided by Yang Huan Jun, Fudan University:
Erlotinib brain radiotherapy NSCLC brain metastases |
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Neoplasms, Second Primary Recurrence Brain Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Neoplastic Processes Pathologic Processes Disease Attributes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |