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

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ClinicalTrials.gov Identifier: NCT00851253
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Minh Tam Truong, Boston Medical Center

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 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




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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

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


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

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:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms