Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

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

Summary: 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.

Detailed 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.

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)

Relevance to patient case: not relevant