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Comparison Study of WBRT and SRS Alone Versus With Temozolomide or Erlotinib in Patients With Brain Metastases of NSCLC

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Erlotinib, Temozolomide
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed non-small cell lung cancer with the presence of 1-3 intraparenchymal brain metastases. A contrast-enhanced MRI demonstrating the presence of 1-3 brain metastases performed within two weeks prior to registration. The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have a maximum diameter of ≤ 4.0 cm in any direction on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter. Patients who present with symptoms of brain metastases at the time of initial diagnosis are eligible and do not need to demonstrate one month of stable scans. Age 18 years or older. Zubrod 0-1 Neurologic Function Status 0, 1, or 2. Patients may have stable extracranial metastases. Contrast-enhancing CT scans of the chest, abdomen and pelvis, and bone scan to determine the extent of extracranial malignant disease. Adequate bone marrow reserve Patients randomized to receive erlotinib who are on enzyme inducing seizure medicines including phenytoin, carbamazepine, rifampicin, barbiturates must be converted to a nonenzyme inducing anti-seizure medication. Patients on Arm 3 will not be able to start treatment immediately if converting. Patient must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative. - Exclusion Criteria: Major medical illnesses or psychiatric impairment Patients who have undergone a complete resection of all known brain metastases.Patients who have undergone subtotal resection are eligible providing residual disease is =/< 4.0 cm in maximum diameter. Inability to obtain histologic proof of NSCLC. Patients with leptomeningeal metastases documented by MRI or CSF evaluation. Clinical or radiographic evidence of progression (other than the study lesion(s)) within one month prior to enrollment. (Patients who have brain metastases at initial presentation are eligible and do not need to demonstrate one month of stable scans). Patients with metastases within 10 mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the high dose SRS boost field. Patients with metastases in the brainstem, midbrain, pons, or medulla. Patients with liver metastases. Previous cranial radiation. Women who are pregnant or nursing Patients who are HIV positive are not eligible. Any evidence of clinically active interstitial lung disease Treatment with a non-approved or investigational drug within 30 days before Day 1 of studytreatment. Concomitant use of St. John's Wort. History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib and temozolomide.

Sites / Locations

  • Tel Aviv Sourasky Medical CenterRecruiting

Outcomes

Primary Outcome Measures

survival

Secondary Outcome Measures

Full Information

First Posted
December 21, 2005
Last Updated
February 27, 2006
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Radiation Therapy Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00268684
Brief Title
Comparison Study of WBRT and SRS Alone Versus With Temozolomide or Erlotinib in Patients With Brain Metastases of NSCLC
Official Title
A Phase III Trial Comparing Whole Brain Radiation (WBRT) and Stereotactic Radiosurgery (SRS) Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Radiation Therapy Oncology Group

4. Oversight

5. Study Description

Brief Summary
The objectives of the study is to determine if either temozolomide or erlotinib combined with WBRT and SRS improves survival as compared to WBRT and SRS alone.Ptients with histologically confirmed NSCLC with the presence of 1-3 intraparenchymal brain metastases will be randomized to 3 arms. All of the patients will receive WBRT and SRS. The patients of the arm 1 will receive radiation treatment only, the arm 2 patients will be treated with temozolomide and arm 3 patients will receive erlotinib

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

7. Study Design

Study Phase
Phase 3
Enrollment
381 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Erlotinib, Temozolomide
Primary Outcome Measure Information:
Title
survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed non-small cell lung cancer with the presence of 1-3 intraparenchymal brain metastases. A contrast-enhanced MRI demonstrating the presence of 1-3 brain metastases performed within two weeks prior to registration. The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have a maximum diameter of ≤ 4.0 cm in any direction on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter. Patients who present with symptoms of brain metastases at the time of initial diagnosis are eligible and do not need to demonstrate one month of stable scans. Age 18 years or older. Zubrod 0-1 Neurologic Function Status 0, 1, or 2. Patients may have stable extracranial metastases. Contrast-enhancing CT scans of the chest, abdomen and pelvis, and bone scan to determine the extent of extracranial malignant disease. Adequate bone marrow reserve Patients randomized to receive erlotinib who are on enzyme inducing seizure medicines including phenytoin, carbamazepine, rifampicin, barbiturates must be converted to a nonenzyme inducing anti-seizure medication. Patients on Arm 3 will not be able to start treatment immediately if converting. Patient must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative. - Exclusion Criteria: Major medical illnesses or psychiatric impairment Patients who have undergone a complete resection of all known brain metastases.Patients who have undergone subtotal resection are eligible providing residual disease is =/< 4.0 cm in maximum diameter. Inability to obtain histologic proof of NSCLC. Patients with leptomeningeal metastases documented by MRI or CSF evaluation. Clinical or radiographic evidence of progression (other than the study lesion(s)) within one month prior to enrollment. (Patients who have brain metastases at initial presentation are eligible and do not need to demonstrate one month of stable scans). Patients with metastases within 10 mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the high dose SRS boost field. Patients with metastases in the brainstem, midbrain, pons, or medulla. Patients with liver metastases. Previous cranial radiation. Women who are pregnant or nursing Patients who are HIV positive are not eligible. Any evidence of clinically active interstitial lung disease Treatment with a non-approved or investigational drug within 30 days before Day 1 of studytreatment. Concomitant use of St. John's Wort. History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib and temozolomide.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Veisenman
Phone
972-36977285
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Bokstein, M.D.
Phone
972-524266532
Email
fbok@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Bokstein, M.D.
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
63409
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Bokstein, M.D.
Phone
972-524266532
Email
fbok@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Debora Blumenthal, M.D.
Phone
972-524266403
Email
dvorab@tasmc.gov.il

12. IPD Sharing Statement

Learn more about this trial

Comparison Study of WBRT and SRS Alone Versus With Temozolomide or Erlotinib in Patients With Brain Metastases of NSCLC

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