Head and Neck Cancer Clinical Trial
Official title:
The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
Verified date | December 2017 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | April 2017 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: DISEASE CHARACTERISTICS: - Biopsy-confirmed* invasive head and neck cancer, including the following primary sites: - Nasopharynx - Oropharynx - Paranasal sinus - Oral cavity - Orbit - Salivary gland NOTE: *Biopsy must be performed prior to initiation of external beam radiotherapy (EBRT) - Stage T2-4 tumor at the time of diagnosis - Primary tumor = 5 cm in diameter at the time of CyberKnife® stereotactic radiosurgery (SRS) - Meets one of the following criteria: - Eligible for CyberKnife® SRS as boost therapy, as defined by one of the following criteria: - Planning to undergo definitive EBRT, with or without chemotherapy, with curative intent for primary head and neck cancer - Biopsy-confirmed locally persistent disease < 3 months after completion of definitive EBRT - Eligible for CyberKnife® SRS as salvage therapy*, as defined by one of the following criteria: - Biopsy-confirmed locally recurrent disease occurring = 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had > 50% of the tumor volume in the prior irradiated volume; and received > 45 Gy of radiotherapy - Biopsy-confirmed locally recurrent disease occurring between 6 weeks and 6 months after the completion of radiotherapy; achieved a complete response to initial therapy by imaging or clinical examination; had < 50% of the tumor volume in the prior irradiated volume; and received > 45 Gy of radiotherapy NOTE: *Not a candidate for salvage surgery or brachytherapy - Anticipated total dose of radiotherapy to the spinal cord = 50 Gy (including prior dose) PATIENT CHARACTERISTICS: - Karnofsky performance status 60-100% - Not pregnant or nursing - Fertile patients must use effective contraception - Able to achieve normal tissue tolerance to critical structures with the CyberKnife® planning system - Able to undergo CT simulation PRIOR CONCURRENT THERAPY: - See Disease Characteristics Exclusion Criteria: - No laryngeal or hypopharyngeal cancer - No evidence of distant metastases - No prior brachytherapy - No prior CyberKnife® SRS boost or salvage therapy - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No active connective tissue disorders (e.g., lupus or scleroderma) |
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 | Duration of Local Control | Median time to local failure based on regional or distant metastatic disease | 1 year | |
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 | 1 year |
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