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

Boston Medical Center (BMC)

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Radiation: stereotactic radiosurgery

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00851253

H-26649

W912SQ7058N601 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group 1 (CK SRS boost therapy)

Experimental group

Description:

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

Treatment:

Radiation: stereotactic radiosurgery

Group 2 (CK SRS salvage therapy)

Experimental group

Description:

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

Treatment:

Radiation: stereotactic radiosurgery