Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases (TRACTS)

Study Description

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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.

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 Design

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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

Arms and Interventions

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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.	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

Outcome Measures

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Primary Outcome Measures :

1. overall survival [ Time Frame: 3.5year ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Over the age of 18 years old;
2. Tissue or cell pathological diagnosis of NSCLC;
3. Brain CT or MR validated BM;
4. Non-increased-intracranial-pressure symptomatic BM;
5. Haven't received TKI target treatment;
6. Haven't received brain radiotherapy;
7. Patients in initial treatment should be detected EGFR mutation;
8. Expected survival more than 6 months;
9. KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain metastases;
10. 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;
11. Routine blood test requirements: WBC≧3.0×109/L, NE≧1.8×109/L, PLT≧90×109/L，no requirement for Hb;
12. Blood glucose requirements: within the normal range, diabetic patients are receiving treatment and their glucose was being controlled in a steady state;
13. Female patients in childbearing age: HCG (-);
14. Patients signed an inform Consent.

Exclusion Criteria:

1. Those with Erlotinib drug allergies;
2. Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
3. Those without guardians or families;
4. 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;
5. 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);
6. 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;
7. Pregnant women.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Huanjun Yang, Master	+86-21-64175590 ext 6723	yanghj_1@hotmail.com

Locations

China
Fudan University Shanghai Cancer Center	Recruiting
Shanghai, China, 200032
Contact: Huanjun Yang, Master +86-21-64175590 ext 6723 yanghj_1@hotmail.com

Sponsors and Collaborators

Wu Jieping Medical Foundation

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

Investigators

Principal Investigator:	Huanjun Yang	Fudan University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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