Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00851253 |
Recruitment Status
:
Completed
First Posted
: February 25, 2009
Results First Posted
: January 17, 2018
Last Update Posted
: January 17, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Radiation: stereotactic radiosurgery | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | April 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1 (CK SRS boost therapy)
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
|
Radiation: stereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses
Other Name: CyberKnife
|
Experimental: Group 2 (CK SRS salvage therapy)
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
|
Radiation: stereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses
Other Name: CyberKnife
|
- Duration of Local Control [ Time Frame: 1 year ]Median time to local failure based on regional or distant metastatic disease
- Rates of Adverse Events Associated With Treatment [ Time Frame: 1 year ]Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851253
United States, Massachusetts | |
Boston University Cancer Research Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Minh T. Truong, MD | Boston University |
Responsible Party: | Minh Tam Truong, BMC Attending Physician, Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT00851253 History of Changes |
Other Study ID Numbers: |
H-26649 W912SQ7058N601 ( Other Grant/Funding Number: Dept of Defense ) |
First Posted: | February 25, 2009 Key Record Dates |
Results First Posted: | January 17, 2018 |
Last Update Posted: | January 17, 2018 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | Yes | |
Device Product Not Approved or Cleared by U.S. FDA: | No | |
Pediatric Postmarket Surveillance of a Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Minh Tam Truong, Boston Medical Center:
salivary gland acinic cell tumor 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 |
Additional relevant MeSH terms:
Head and Neck Neoplasms Neoplasms by Site Neoplasms |