Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Radiation: stereotactic radiosurgery	Not Applicable

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Duration of Local Control [ Time Frame: 1 year ]
   Median time to local failure based on regional or distant metastatic disease

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Locations

United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston Medical Center

United States Department of Defense

Investigators

Principal Investigator:	Minh T. Truong, MD	Boston University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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