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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00268684
First received: December 21, 2005
Last updated: February 27, 2006
Last verified: December 2005
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Drug: Erlotinib, Temozolomide
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • survival

Estimated Enrollment: 381
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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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.
  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: NCT00268684

Contacts
Contact: Lina Veisenman 972-36977285
Contact: Felix Bokstein, M.D. 972-524266532 fbok@netvision.net.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 63409
Contact: Felix Bokstein, M.D.    972-524266532    fbok@netvision.net.il   
Contact: Debora Blumenthal, M.D.    972-524266403    dvorab@tasmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Felix Bokstein, M.D. Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00268684     History of Changes
Other Study ID Numbers: TASMC-05-FB-05235-CTIL
Study First Received: December 21, 2005
Last Updated: February 27, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Temozolomide
Dacarbazine
Erlotinib
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014