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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: stereotactic radiosurgery

• Registration Number: NCT00851253
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2014-12
• Study Completion: 2017-04
• Results First Submitted: 2017-07-10
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-17
• Last Update Submitted: 2017-12-17
• Results First Posted: 2018-01-17
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (CK SRS salvage therapy)	stereotactic radiosurgery	Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
Group 1 (CK SRS boost therapy)	stereotactic radiosurgery	Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.

Primary Outcome Measures

Name	Time	Method
Duration of Local Control	1 year	Median time to local failure based on regional or distant metastatic disease

Secondary Outcome Measures

Name	Time	Method
Rates of Adverse Events Associated With Treatment	1 year	Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment

Trial Locations

Locations (1)

Boston University Cancer Research Center; 🇺🇸 Boston, Massachusetts, United States