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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268684
Recruitment Status : Unknown
Verified December 2005 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : December 22, 2005
Last Update Posted : February 28, 2006
Radiation Therapy Oncology Group
Information provided by:
Tel-Aviv Sourasky Medical Center

December 21, 2005
December 22, 2005
February 28, 2006
May 2005
Not Provided
Same as current
Complete list of historical versions of study NCT00268684 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Comparison Study of WBRT and SRS Alone Versus With Temozolomide or Erlotinib in Patients With Brain Metastases of NSCLC
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
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
Not Provided
Phase 3
Not Provided
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis
Drug: Erlotinib, Temozolomide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
Not Provided

Inclusion Criteria:

  1. Histologically confirmed non-small cell lung cancer with the presence of 1-3 intraparenchymal brain metastases.
  2. A contrast-enhanced MRI demonstrating the presence of 1-3 brain metastases performed within two weeks prior to registration.
  3. 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.
  4. 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.
  5. Age 18 years or older.
  6. Zubrod 0-1
  7. Neurologic Function Status 0, 1, or 2.
  8. Patients may have stable extracranial metastases.
  9. Contrast-enhancing CT scans of the chest, abdomen and pelvis, and bone scan to determine the extent of extracranial malignant disease.
  10. Adequate bone marrow reserve
  11. 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.
  12. 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:

  1. Major medical illnesses or psychiatric impairment
  2. 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.
  3. Inability to obtain histologic proof of NSCLC.
  4. Patients with leptomeningeal metastases documented by MRI or CSF evaluation.
  5. 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).
  6. 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.
  7. Patients with metastases in the brainstem, midbrain, pons, or medulla.
  8. Patients with liver metastases.
  9. Previous cranial radiation.
  10. Women who are pregnant or nursing
  11. Patients who are HIV positive are not eligible.
  12. Any evidence of clinically active interstitial lung disease
  13. Treatment with a non-approved or investigational drug within 30 days before Day 1 of studytreatment.
  14. Concomitant use of St. John’s Wort.
  15. History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib and temozolomide.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
Radiation Therapy Oncology Group
Principal Investigator: Felix Bokstein, M.D. Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
December 2005

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