Lung Cancer Clinical Trial
Official title:
Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
Verified date | April 2018 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | August 2016 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 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 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) |
Country | Name | City | State |
---|---|---|---|
United States | Boston University Cancer Research Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 weeks | |
Primary | 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. | 6 weeks | |
Primary | 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 | 6 weeks | |
Primary | 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. | 6 weeks | |
Secondary | 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 | before treatment and at 1, 3, 6, and 12 months after treatment |
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