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About
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib may also make tumor cells more sensitive to radiation therapy. It is not yet known whether giving whole-brain radiation therapy together with erlotinib is more effective than whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and brain metastases.
PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and erlotinib to see how well they work compared with whole-brain radiation therapy alone in treating patients with advanced non-small cell lung cancer and brain metastases.
Full description
OBJECTIVES:
Primary
Compare the effect of whole-brain radiotherapy (WBRT) and erlotinib hydrochloride vs WBRT alone on neurological progression-free survival at 2 months in patients with advanced non-small cell lung cancer and multiple brain metastases.
Secondary
Compare the toxicity of these regimens. Compare the response rate in these patients. Compare quality of life of these patients. Compare change in performance status in these patients. Compare steroid dosing in these patients. Compare sites of progression (cranial or extracranial) in these patients.
OUTLINE: This is a multicenter study. Patients are stratified by presence of extracranial metastases (yes vs no), RTOG recursive partitioning analysis (RPA) score (I vs II) and treatment center. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily for 5 days. Patients also receive oral erlotinib hydrochloride once daily for up to 24 months. Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once daily for up to 24 months.
Quality of life is assessed at baseline, monthly for 12 months, and then at 18 and 24 months.
After completion of study therapy, patients are followed every 1-2 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
Diagnosis of brain metastases must be confirmed by contrast CT scan or MRI within the past 4 weeks
Clinician certain that whole-brain radiotherapy (WBRT) will be beneficial
No evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
No more than 3 sites (organ systems) of extracranial metastases
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
RTOG recursive partitioning analysis (RPA) class I or II
Serum bilirubin < 2 times upper limit of normal (ULN)
AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
Creatinine < 5 times ULN
Able to take oral medication
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Caretaker able and willing to participate in the study
Patient and caretaker have access to a telephone and willing to respond to telephone interview
No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 28 days since prior chemotherapy (for relapsed patients originally treated with chemotherapy)
No prior cranial radiotherapy
No prior anti-cancer EGFR therapy (e.g., erlotinib, gefitinib, or cetuximab)
No prior treatment for brain metastases (e.g., radiosurgery, radiotherapy, or chemotherapy)
No concurrent cyclooxygenase-2 (COX-2) inhibitors
Primary purpose
Allocation
Interventional model
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80 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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