NCT00096265

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Compare survival in patients with non-small cell lung cancer and brain metastases treated with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomide or erlotinib. SECONDARY OBJECTIVES: I. Compare time to CNS progression in patients treated with these regimens. II. Compare quality-adjusted survival in patients treated with these regimens. III. Compare 3-month quality of life in patients treated with these regimens. IV. Compare the 6-month performance status of patients treated with these regimens. V. Compare 6-month steroid dependence in patients treated with these regimens. VI. Compare cause of death (neurologic vs other) in patients treated with these regimens. VII. Determine the effects of non-protocol chemotherapy in these patients. 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. ARM I: 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. ARM II: 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. ARM III: 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. 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.

Conditions

• Metastatic Malignant Neoplasm in the Brain
• Recurrent Non-Small Cell Lung Carcinoma
• Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions

Type	Name	Description
RADIATION	3-Dimensional Conformal Radiation Therapy	Patients undergo radiation therapy once daily for approximately 3 weeks
DRUG	Erlotinib Hydrochloride	Given orally
RADIATION	Stereotactic Radiosurgery	Patients undergo surgery after radiation therapy
DRUG	Temozolomide	Given orally

Timeline

• Start date: 2004-10-06
• Primary completion: 2011-06-14
• Completion: 2012-04-01
• First posted: 2004-11-09
• Last updated: 2018-03-09
• Results posted: 2013-04-16

Locations

83 sites across 2 countries: United States, Canada