N/A
N=12
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00851253 ↗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
| Outcome | Result | p-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)
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.