Clinical trial NCT00851253: Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Official title: The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: 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
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 mucoepidermoid carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral 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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-02-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 radiosurgery in treating patients with locally advanced or recurrent head and neck cancer.

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 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.

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 \< 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 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)

Primary outcomes:
measure: Duration of Local Control
timeFrame: 1 year
Secondary outcomes:
measure: Rates of Adverse Events Associated With Treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Minh T. Truong, MD
role: PRINCIPAL_INVESTIGATOR
References: