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

NCT ID: NCT00851253

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2017-04-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (CK SRS boost therapy)

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

Group Type: EXPERIMENTAL

stereotactic radiosurgery

Intervention Type: RADIATION

Given in 2 fractionated doses or 5 fractionated doses

Group 2 (CK SRS salvage therapy)

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

Group Type: EXPERIMENTAL

stereotactic radiosurgery

Intervention Type: RADIATION

Given in 2 fractionated doses or 5 fractionated doses

Interventions

stereotactic radiosurgery

Given in 2 fractionated doses or 5 fractionated doses

Intervention Type: RADIATION

Other Intervention Names

CyberKnife

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Minh Tam Truong

BMC Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minh T. Truong, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University Cancer Research Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

W912SQ7058N601

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-26649

Identifier Type: -

Identifier Source: org_study_id