RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
OBJECTIVES: * To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer. * To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment. OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks. Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment. After completion of study treatment, patients are followed periodically for up to 4 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
Boston University Cancer Research Center
Boston, Massachusetts, United States
Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
Time frame: 6 weeks
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Time frame: 6 weeks
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
Time frame: 6 weeks
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Time frame: 6 weeks
Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
Time frame: before treatment and at 1, 3, 6, and 12 months after treatment
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CyberKnife radiosurgery