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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: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
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
| ClinicalTrials.gov Identifier: | NCT00030836 History of Changes |
| Other Study ID Numbers: | CDR0000069201, MSKCC-01133, SPRI-P02143, NCI-G01-2048 |
| Study First Received: | February 14, 2002 |
| Last Updated: | December 3, 2009 |
| Health Authority: | United States: Federal Government |
|
tumors metastatic to brain |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |