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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00096265 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Lung Cancer |
Drug: erlotinib hydrochloride Drug: temozolomide Procedure: radiation therapy Procedure: stereotactic radiosurgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Trial Comparing Whole Brain Radiation And Stereotactic Radiosurgery Alone Versus With Temozolomide Or Erlotinib In Patients With Non-Small Cell Lung Cancer And 1-3 Brain Metastases |
Estimated Enrollment: | 381 |
Study Start Date: | October 2004 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
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Procedure: radiation therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Procedure: stereotactic radiosurgery
Patients undergo surgery after radiation therapy
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Arm II: Experimental
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Drug: temozolomide
Given orally
Procedure: radiation therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Procedure: stereotactic radiosurgery
Patients undergo surgery after radiation therapy
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Arm III: Experimental
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
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Drug: erlotinib hydrochloride
Given orally
Procedure: radiation therapy
Patients undergo radiation therapy once daily for approximately 3 weeks
Procedure: stereotactic radiosurgery
Patients undergo surgery after radiation therapy
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and the presence of extracranial metastases (< 65 years old AND no extracranial metastases vs ≥ 65 years old OR extracranial metastases), number of metastases (1 vs 2 or 3), and extent of extracranial disease (none vs present). Patients are randomized to 1 of 3 treatment arms.
In all arms, patients with recurrent brain metastases may undergo additional stereotactic radiosurgery.
Quality of life is assessed at baseline and at 3, 6, 9, 12, 18, and 24 months.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 381 patients (127 per treatment arm) will be accrued for this study within 70 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
Maximum diameter ≤ 4.0 cm
No prior complete resection of all known brain metastases
No clinical or radiographic evidence of progression (other than study lesion[s]) within the past month
Stable extracranial metastases allowed
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
No clinically active interstitial lung disease
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No other concurrent chemotherapy during study radiotherapy
Other concurrent chemotherapy allowed after study radiotherapy, except for the following:
Endocrine therapy
Radiotherapy
Concurrent radiotherapy to painful bone lesions allowed
Surgery
Other
No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following (for patients randomized to receive erlotinib):
Study Chair: | Paul Sperduto, MD, MAPP | Park Nicollet Cancer Center |
Investigator: | Minesh P. Mehta, MD | University of Wisconsin, Madison |
Investigator: | H. I. Robins, MD, PhD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000389490, RTOG-0320 |
Study First Received: | November 9, 2004 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00096265 |
Health Authority: | Unspecified |
adult tumors metastatic to brain recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Central Nervous System Neoplasms Temozolomide Recurrence Carcinoma |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |