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

Head and Neck Cancer Clinical Trial

Official title:

The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851253
• Other study ID #: H-26649
• Secondary ID: W912SQ7058N601
• Status: Completed
• Phase: N/A
• First received: February 24, 2009
• Last updated: December 17, 2017
• Start date: January 2009
• Est. completion date: April 2017

Study information

• Verified date: December 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• stereotactic radiosurgery
Given in 2 fractionated doses or 5 fractionated doses

Locations

Country	Name	City	State
United States	Boston University Cancer Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Local Control	Median time to local failure based on regional or distant metastatic disease	1 year
Secondary	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	1 year