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

This study is currently recruiting participants.
Verified December 2013 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00851253
First received: February 24, 2009
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Head and Neck Cancer
Radiation: stereotactic radiosurgery
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Proportion of patients maintaining local control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rates of adverse events associated with treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: February 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (CyberKnife® SRS boost therapy)
Patients undergo CyberKnife® SRS boost therapy (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
Radiation: stereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses
Experimental: Group 2 (CyberKnife® SRS salvage therapy)
Patients undergo CyberKnife® SRS salvage therapy (5 fractions) 3 times weekly.
Radiation: stereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • No laryngeal or hypopharyngeal cancer
  • No evidence of distant metastases

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
  • 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)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior brachytherapy
  • No prior CyberKnife® SRS boost or salvage therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851253

Locations
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen    617-638-8265      
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Minh T. Truong, MD Boston University
  More Information

Additional Information:
No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00851253     History of Changes
Other Study ID Numbers: CDR0000635094, BUMC-H-26649
Study First Received: February 24, 2009
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
recurrent adenoid cystic carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
salivary gland adenoid cystic carcinoma
stage IV adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous 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
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity

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

ClinicalTrials.gov processed this record on April 22, 2014