Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatment stereotactic radiosurgery
Phase phase 1
Sponsor Boston Medical Center
Collaborator United States Department of Defense
Start date January 2009
End date December 2014
Trial size 30 participants
Trial identifier NCT00851253, BUMC-H-26649, CDR0000635094

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery CyberKnife
Given in 2 fractionated doses or 5 fractionated doses
(Experimental)
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery CyberKnife
Given in 2 fractionated doses or 5 fractionated doses

Primary Outcomes

Measure
Proportion of patients maintaining local control
time frame: 2 years

Secondary Outcomes

Measure
Rates of adverse events associated with treatment
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer
Principal investigator Minh T. Truong, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.