Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases (TRACTS)
This study is currently recruiting participants.
Verified March 2013 by Wu Jieping Medical Foundation
Sponsor:
Wu Jieping Medical Foundation
Collaborators:
Fudan University
Changhai Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Longhua Hospital Shanghai University of TCM
RenJi Hospital
Shanghai Armed Police Hospital
Shanghai Chest Hospital
Shanghai Xinhua Hospital
Shanghai Changzheng Hospital
Information provided by (Responsible Party):
Yang Huan Jun, Fudan University
ClinicalTrials.gov Identifier:
NCT01763385
First received: January 4, 2013
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-small-cell Lung Cancer Brain Metastases |
Drug: Erlotinib Radiation: concurrent brain radiotherapy Radiation: secondary brain radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Wu Jieping Medical Foundation:
Primary Outcome Measures:
- overall survival [ Time Frame: 3.5year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 210 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763385
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 Shanghai University of TCM
RenJi Hospital
Shanghai Armed Police Hospital
Shanghai Chest Hospital
Shanghai Xinhua Hospital
Shanghai Changzheng Hospital
Investigators
| Principal Investigator: | Huanjun Yang | Fudan University |
More Information
No publications provided
| Responsible Party: | Yang Huan Jun, Fudan University |
| ClinicalTrials.gov Identifier: | NCT01763385 History of Changes |
| Other Study ID Numbers: | 2012-75-634 |
| Study First Received: | January 4, 2013 |
| Last Updated: | March 25, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Wu Jieping Medical Foundation:
|
Erlotinib brain radiotherapy NSCLC brain metastases |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Recurrence Brain Neoplasms Carcinoma, Bronchogenic Bronchial 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 Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013