Status:
COMPLETED
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00851253
Start Date
January 1 2009
End Date
April 1 2017
Last Update
January 17 2018
Active Locations (1)
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1
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118