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The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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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 CenterBoston, Massachusetts  02118