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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 (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

January 4, 2013
May 24, 2013
November 2012
May 2016   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 3.5year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01763385 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-small-cell Lung Cancer
  • Brain Metastases
  • Drug: Erlotinib
  • Radiation: concurrent brain radiotherapy
  • Radiation: secondary brain radiotherapy
  • Experimental: Erlotinib & secondary brain radiotherapy
    Erlotinib until brain tumor progression, then given brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression.
    Interventions:
    • 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
    Interventions:
    • Drug: Erlotinib
    • Radiation: concurrent brain radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
May 2016
May 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Huanjun Yang, Master +86-21-64175590 ext 6723 yanghj_1@hotmail.com
China
 
NCT01763385
2012-75-634
Yes
Yang Huan Jun, Fudan University
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
Principal Investigator: Huanjun Yang Fudan University
Wu Jieping Medical Foundation
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP