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

Status: Completed
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Massachusetts
Boston University Cancer Research Center
Boston
Time Frame
Start Date: January 2009
Completion Date: April 2017
Participants
Target number of participants: 12
Treatments
Experimental: Group 1 (CK SRS boost therapy)
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
Experimental: Group 2 (CK SRS salvage therapy)
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
Sponsors
Leads: Boston Medical Center
Collaborators: United States Department of Defense

This content was sourced from clinicaltrials.gov

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