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N/A N=12 Treatment

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

Head and Neck Cancer

Enrolled (actual)
12
Serious AEs
90.9%
Results posted
Jan 2018
Primary outcome: Primary: Duration of Local Control — 4.6 number of months to local failure

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
stereotactic radiosurgery (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boston Medical Center
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Duration of Local Control
4.6
SECONDARY
Rates of Adverse Events Associated With Treatment
1; 0

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.

Eligibility Criteria

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 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 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00851253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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