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

December 22, 2014 updated by: Yang Huan Jun, Wu Jieping Medical Foundation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3.5year
3.5year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wu Jieping Medical Foundation

Collaborators

Changhai Hospital
Fudan University
RenJi Hospital
Shanghai Chest Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai Changzheng Hospital
Longhua Hospital
Shanghai Armed Police Hospital

Investigators

  • Principal Investigator: Huanjun Yang, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

January 4, 2013

First Submitted That Met QC Criteria

January 7, 2013

First Posted (ESTIMATE)

January 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-75-634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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