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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stereotactic radiosurgery
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boston University Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 (CK SRS boost therapy)

Group 2 (CK SRS salvage therapy)

Arm Description

Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.

Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.

Outcomes

Primary Outcome Measures

Duration of Local Control
Median time to local failure based on regional or distant metastatic disease

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2009
Last Updated
December 17, 2017
Sponsor
Boston Medical Center
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00851253
Brief Title
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Official Title
The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minh T. Truong, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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