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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000635119 | Other Grant/Funding Number | Department of Defense |
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poor accrual
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 56 Gray (LESS than 3 centimeter cohort) | Experimental | 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 |
|
| 62 Gray (LESS than 3 centimeter cohort) | Experimental | 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 |
|
| 68 Gray (LESS than 3 centimeter cohort) | Experimental | 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 |
|
| 56 Gray (MORE than 3 centimeter cohort) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computed tomography | Procedure | Standard CT scans |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Stage I or II disease (T1-3, N0, M0)
Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
PATIENT CHARACTERISTICS:
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Minh Tam Truong, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
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9 patients were enrolled onto this study between January 2009 and August 2012 in the Radiation Oncology Clinic at Boston Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 at 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
| FG001 | 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 at 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
| FG002 | 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 at 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
| FG003 | 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 at 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
| FG004 | 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 a 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
| FG005 | 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 at 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CyberKnife | 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 Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
The highest tolerable dose was not established in either cohort due to early termination. There were no dose limiting toxicities experienced at 56 or 62 gray (less than 3 centimeters) or 56 gray (more than 3 centimeters) at the time of study closure
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Minh Tam Truong | Boston Medical Center | 617-638-7070 | minh-tam.truong@bmc.org |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D011878 | Radiotherapy |
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Participants to receive Cyberknife radiation therapy in 4 doses over two weeks. Dose will be determined using a dose-escalation plan.
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| Experimental |
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 |
|
| 62 Gray (MORE than 3 centimeter cohort) | Experimental | 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 |
|
| 68 Gray (MORE than 3 centimeter cohort) | Experimental | 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 |
|
| fludeoxyglucose F 18 | Radiation | standard doses with CT scans |
|
| hypofractionated radiation therapy | Radiation | 4 doses over 2 weeks |
|
| stereotactic radiosurgery | Radiation | CyberKnife radiosurgery |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Dose 3 (68 gray), less than 3 centimeter cohort |
|
|
| 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. | The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early. | Posted | 6 weeks | dose | dose |
|
|
| 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 | Posted | Count of Participants | Participants | 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. | The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early. | Posted | 6 weeks | dose | dose |
|
|
| 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 | Data were not collected and the outcome measure was not analyzed | Posted | before treatment and at 1, 3, 6, and 12 months after treatment |
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 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 | 0 | 3 | 2 | 3 | 3 | 3 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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 | 0 | 3 | 1 | 3 | 3 | 3 |
| EG004 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| diabetes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diffusing capacity of the lungs for carbon monoxide (DLCO) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| gait/walking | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| gait/walking | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Presented to Emergency Department with chest pain. Treated for non-ST segment elevation myocardial infarction) - Grade 1 |
|
| constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| fibrosis-deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| musculoskeletal-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | left sided muscle soreness |
|
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| pulmonary fibrosis | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| voice changes | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D013812 |
| Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |