Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Sponsor||Boston Medical Center|
|Collaborator||United States Department of Defense|
|Start date||January 2009|
|End date||December 2014|
|Trial size||30 participants|
|Trial identifier||NCT00851253, BUMC-H-26649, CDR0000635094|
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.
|Intervention model||parallel assignment|
Proportion of patients maintaining local control
time frame: 2 years
Rates of adverse events associated with treatment
time frame: 2 years
Male or female participants at least 18 years old.
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)
|Official title||The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer|
|Principal investigator||Minh T. Truong, MD|
|Description||OBJECTIVES: - To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as boost therapy after standard chemoradiotherapy in patients with locally advanced head and neck cancer. - To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery as salvage therapy in patients with locally recurrent head and neck cancer. 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. - Group 1 (CyberKnife® SRS boost therapy): Patients undergo CyberKnife® SRS boost therapy (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. - Group 2 (CyberKnife® SRS salvage therapy): Patients undergo CyberKnife® SRS salvage therapy (5 fractions) 3 times weekly. After completion of study treatment, patients are followed periodically for up to 2 years.|
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