Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Treatments||computed tomography, fludeoxyglucose f 18, hypofractionated radiation therapy, stereotactic radiosurgery|
|Sponsor||Boston Medical Center|
|Collaborator||United States Department of Defense|
|Start date||January 2009|
|End date||June 2013|
|Trial size||36 participants|
|Trial identifier||NCT00852644, BUMC-H-26701, CDR0000635119|
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.
|Intervention model||single group assignment|
To establish the maximally tolerated dose of CyberKnife® radiosurgery in patients with medically inoperable clinical Tl-3 N0 M0 NSCLC
time frame: 6 weeks
Relationship between 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
Male or female participants at least 18 years old.
Inclusion Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Stage I or II disease (T1-3, N0, M0) - T2 or T3 tumor ≤ 5 cm - No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed) - Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable" - Patients with FDG-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Not pregnant or nursing - Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment Exclusion Criteria: - No history of contrast allergy - No psychological issues that would preclude the completion of study treatment PRIOR CONCURRENT THERAPY: - No prior radiotherapy or chemotherapy - No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan) - No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
|Official title||Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer|
|Principal investigator||Lisa A. Kachnic, MD|
|Description||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 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.|
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