Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

Stopped early · Phase 3

Conditions studied: Metastatic Malignant Neoplasm in the Brain, Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7

In brief

This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radiation therapy and stereotactic radiosurgery in treating patients with brain metastases secondary to non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by blocking blood flow to the tumor. It is not yet known whether radiation therapy and stereotactic radiosurgery are more effective with or without temozolomide or erlotinib in treating brain metastases.

Key facts

Study ID

NCT00096265

Run by

National Cancer Institute (NCI)

People needed

126

Starts

2004-10-06

Expected to finish

2012-04-01

Last updated by the study team

2018-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-small cell lung cancer
• One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
• Well circumscribed tumor(s)
• Maximum diameter ≤ 4.0 cm
• If multiple lesions are present and one lesion is at the maximum diameter, the other lesions must not exceed 3.0 cm in maximum diameter
• No metastases within 10 mm of the optic apparatus such that a portion of the optic nerve or chiasm would be included in the high-dose stereotactic radiosurgery boost field
• No metastases in the brainstem, midbrain, pons, or medulla
• No prior complete resection of all known brain metastases
• Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter
• No clinical or radiographic evidence of progression (other than study lesion[s]) within the past month
• Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease
• Stable extracranial metastases allowed
• No known or pre-existing liver metastases
• No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
• Synchronous brain metastases at initial diagnosis allowed
• Performance status - Zubrod 0-1
• Hemoglobin ≥ 8 g/dL
• Absolute neutrophil count ≥ 1,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• AST < 2 times upper limit of normal (ULN)
• Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases
• Total bilirubin normal
• Lactic dehydrogenase < 2 times ULN
• Creatinine < 1.5 times ULN
• No clinically active interstitial lung disease

Where it is running

• Scottsdale Health Care-Osborn — Scottsdale, Arizona, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Pomona Valley Hospital Medical Center — Pomona, California, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Southside Cancer Center — Jacksonville, Florida, United States
• Baptist Medical Center South — Jacksonville, Florida, United States
• Integrated Community Oncology Network-Florida Cancer Center Beaches — Jacksonville Beach, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• 21st Century Oncology-Orange Park — Orange Park, Florida, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• 21st Century Oncology-Palatka — Palatka, Florida, United States
• Bay Medical Center — Panama City, Florida, United States
• Integrated Community Oncology Network-Flager Cancer Center — Saint Augustine, Florida, United States
• Tallahassee Memorial HealthCare — Tallahassee, Florida, United States
• John B Amos Cancer Center — Columbus, Georgia, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Northwest Community Hospital — Arlington Heights, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Saint John's Hospital — Springfield, Illinois, United States
• Parkview Hospital Randallia — Fort Wayne, Indiana, United States
• Arizona Oncology Services Foundation — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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