The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
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.
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)
- No laryngeal or hypopharyngeal cancer
- No evidence of distant metastases
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
- 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)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior brachytherapy
- No prior CyberKnife® SRS boost or salvage therapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients maintaining local control
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Minh T. Truong, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Boston University
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000635094
NCT ID:
NCT00851253
Start Date:
January 2009
Completion Date:
February 2014
Related Keywords:
- Head and Neck Cancer
- recurrent adenoid cystic carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- recurrent verrucous carcinoma of the oral cavity
- stage II adenoid cystic carcinoma of the oral cavity
- stage II mucoepidermoid carcinoma of the oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage III adenoid cystic carcinoma of the oral cavity
- stage III mucoepidermoid carcinoma of the oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- recurrent basal cell carcinoma of the lip
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage II basal cell carcinoma of the lip
- stage III basal cell carcinoma of the lip
- recurrent lymphoepithelioma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage II lymphoepithelioma of the nasopharynx
- stage II squamous cell carcinoma of the nasopharynx
- stage III lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- recurrent lymphoepithelioma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage II lymphoepithelioma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage II inverted papilloma of the paranasal sinus and nasal cavity
- stage II midline lethal granuloma of the paranasal sinus and nasal cavity
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- stage III midline lethal granuloma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- high-grade salivary gland mucoepidermoid carcinoma
- low-grade salivary gland mucoepidermoid carcinoma
- recurrent salivary gland cancer
- salivary gland acinic cell tumor
- salivary gland adenocarcinoma
- salivary gland adenoid cystic carcinoma
- salivary gland anaplastic carcinoma
- salivary gland malignant mixed cell type tumor
- salivary gland poorly differentiated carcinoma
- salivary gland squamous cell carcinoma
- stage II salivary gland cancer
- stage III salivary gland cancer
- stage IV adenoid cystic carcinoma of the oral cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV verrucous carcinoma of the oral cavity
- stage IV salivary gland cancer
- stage IV lymphoepithelioma of the nasopharynx
- stage IV lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage IV basal cell carcinoma of the lip
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Boston University Cancer Research Center | Boston, Massachusetts 02118 |
