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| ID | Type | Description | Link |
|---|---|---|---|
| W912SQ7058N601 | Other Grant/Funding Number | Dept of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects of stereotactic radiosurgery in treating patients with locally advanced or recurrent head and neck cancer.
OBJECTIVES:
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to disease status after prior standard therapy. Patients with residual disease after standard therapy are assigned to group 1. Patients with recurrent disease ≥ 6 months after standard therapy are assigned to group 2.
All patients undergo placement of 3-6 gold fiducial markers within 1-2 weeks of beginning CyberKnife® stereotactic radiosurgery (SRS) treatment.
After completion of study treatment, patients are followed periodically for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (CK SRS boost therapy) | Experimental | Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. |
|
| Group 2 (CK SRS salvage therapy) | Experimental | Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic radiosurgery | Radiation | Given in 2 fractionated doses or 5 fractionated doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Local Control | Median time to local failure based on regional or distant metastatic disease | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Adverse Events Associated With Treatment | Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment | 1 year |
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Inclusion Criteria:
DISEASE CHARACTERISTICS:
Biopsy-confirmed* invasive head and neck cancer, including the following primary sites:
Stage T2-4 tumor at the time of diagnosis
Meets one of the following criteria:
Eligible for CyberKnife® SRS as boost therapy, as defined by one of the following criteria:
Eligible for CyberKnife® SRS as salvage therapy*, as defined by one of the following criteria:
Anticipated total dose of radiotherapy to the spinal cord ≤ 50 Gy (including prior dose)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minh T. Truong, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
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One subject that was enrolled onto the Boost Arm was withdrawn prior to undergoing cyberknife therapy due to disease progression.
Participants were recruited from within the investigators clinic practice between February 2009 and August 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (CK SRS Boost Therapy) | Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses |
| FG001 | Group 2 (CK SRS Salvage Therapy) | Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (CK SRS Boost Therapy) | Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses |
| BG001 | Group 2 (CK SRS Salvage Therapy) |
| 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 | Duration of Local Control | Median time to local failure based on regional or distant metastatic disease | Boost subjects were not evaluable. | Posted | Median | Standard Deviation | number of months to local failure | 1 year |
|
1 year
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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 | Group 1 (CK SRS Boost Therapy) | Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Minh Tam Truong | Boston Medical Center | 617-638-7070 | Minh-Tam.Truong@bmc.org |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Rates of Adverse Events Associated With Treatment | Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment | One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | Group 2 (CK SRS Salvage Therapy) | Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses | 1 | 10 | 9 | 10 | 10 | 10 |
| pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| ulceration | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| hemorrhage | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| hemoglobinemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| osteonecrosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| osteomyelitis | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| edema - head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| gait disturbance | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| lypmphatics disorder - other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | moderate secretions from tracheotomy |
|
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| taste alteration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| neurology - other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | headaches 6/10 at worst controlled with pain medication |
|
| dermatitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |