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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030836 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of radiation therapy plus temozolomide to that of radiation therapy alone in treating patients who have non-small cell lung cancer that is metastatic to the brain.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Drug: temozolomide Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase II Study Of Temozolomide (SCH 52365) In Subjects With Brain Metastasis From Nonsmall Cell Lung Cancer |
| Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and recursive partitioning analysis classification (1 vs 2). Patients are randomized to 1 of 2 treatment arms.
Patients are followed at 30 days and then every 8 weeks thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Lauren E. Abrey, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000069201, MSKCC-01133, SPRI-P02143, NCI-G01-2048 |
| Study First Received: | February 14, 2002 |
| Last Updated: | August 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00030836 History of Changes |
| Health Authority: | United States: Federal Government |
|
tumors metastatic to brain |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents 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 |