Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

Completed · Not applicable

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00851253

Run by

Boston Medical Center

People needed

12

Starts

2009-01-01

Expected to finish

2017-04-01

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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)

Where it is running

• Boston University Cancer Research Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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