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Sponsors and Collaborators: |
Tel-Aviv Sourasky Medical Center RTOG |
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Information provided by: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT00268684 |
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 |
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Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis |
Drug: Erlotinib, Temozolomide |
Phase III |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contact: Lina Veisenman | 972-36977285 | |
Contact: Felix Bokstein, M.D. | 972-524266532 | fbok@netvision.net.il |
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 |
Principal Investigator: | Felix Bokstein, M.D. | Tel-Aviv Sourasky Medical Center |
Study ID Numbers: | TASMC-05-FB-05235-CTIL |
Study First Received: | December 21, 2005 |
Last Updated: | February 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00268684 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Erlotinib Protein Kinase Inhibitors Temozolomide Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Neoplasm Metastasis Non-small Cell Lung Cancer Antineoplastic Agents, Alkylating Carcinoma, Non-Small-Cell Lung Alkylating Agents Neoplasms, Glandular and Epithelial |
Erlotinib Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Temozolomide Pharmacologic Actions Carcinoma Neoplasms |
Neoplastic Processes Pathologic Processes Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Neoplasm Metastasis Antineoplastic Agents, Alkylating Alkylating Agents Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |