Head and Neck Cancer
Conditions
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
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.
Interventions
RADIATIONstereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses
Sponsors
United States Department of Defense
Boston Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Local Control | 1 year | Median time to local failure based on regional or distant metastatic disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Adverse Events Associated With Treatment | 1 year | Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from within the investigators clinic practice between February 2009 and August 2013
Pre-assignment details
One subject that was enrolled onto the Boost Arm was withdrawn prior to undergoing cyberknife therapy due to disease progression.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (CK SRS Boost Therapy) Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses | 2 |
| Group 2 (CK SRS Salvage Therapy) Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses | 10 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease Progression | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 (CK SRS Boost Therapy) | Group 2 (CK SRS Salvage Therapy) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 1 / 10 |
| other Total, other adverse events | 1 / 1 | 10 / 10 |
| serious Total, serious adverse events | 1 / 1 | 9 / 10 |
Outcome results
Primary
Duration of Local Control
Median time to local failure based on regional or distant metastatic disease
Time frame: 1 year
Population: Boost subjects were not evaluable.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Group 2 (CK SRS Salvage Therapy) | Duration of Local Control | 4.6 number of months to local failure | Standard Deviation 1.6 |
Secondary
Rates of Adverse Events Associated With Treatment
Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment
Time frame: 1 year
Population: One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (CK SRS Boost Therapy) | Rates of Adverse Events Associated With Treatment | 1 Participants |
| Group 2 (CK SRS Salvage Therapy) | Rates of Adverse Events Associated With Treatment | 0 Participants |