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. (see Contacts and Locations)
Verified May 2013 by Wu Jieping Medical Foundation
Sponsor:
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
Information provided by (Responsible Party):
Yang Huan Jun, Fudan University
ClinicalTrials.gov Identifier:
NCT01763385
First received: January 4, 2013
Last updated: May 24, 2013
Last verified: May 2013
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

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: May 24, 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
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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014