Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
NCT ID: NCT00852644
Last Updated: 2018-05-11
Study Results
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View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2009-01-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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56 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
computed tomography
Standard CT scans
fludeoxyglucose F 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery
62 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
computed tomography
Standard CT scans
fludeoxyglucose F 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery
68 Gray (LESS than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
computed tomography
Standard CT scans
fludeoxyglucose F 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery
56 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
computed tomography
Standard CT scans
fludeoxyglucose F 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery
62 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
computed tomography
Standard CT scans
fludeoxyglucose F 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery
68 Gray (MORE than 3 centimeter cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
computed tomography
Standard CT scans
fludeoxyglucose F 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery
Interventions
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computed tomography
Standard CT scans
fludeoxyglucose F 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery
Eligibility Criteria
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Inclusion Criteria
* 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 fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
PATIENT CHARACTERISTICS:
* Eastern Cooperative Oncology Group (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 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)
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Boston Medical Center
OTHER
Responsible Party
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Minh Tam Truong
Chair and Associate Professor, Radiation Oncology
Principal Investigators
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Minh Tam Truong, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston University Cancer Research Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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CDR0000635119
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-26701
Identifier Type: -
Identifier Source: org_study_id
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