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Stereotactic or Hypofractionated Radiation Therapy in Treating Patients with Recurrent or Metastatic Head and Neck Cancer

Trial Status: Active

This phase I trial studies the side effects and best dose of stereotactic or hypofractionated radiation therapy in treating patients with head and neck cancer that has returned after a period of improvement or has spread to other places in the body. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated intensity-modulated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving stereotactic and hypofractionated radiation therapy may work better in treating patients with head and neck cancer.

Inclusion Criteria

  • Participants must have a pathologic cancer diagnosis: * COHORT I: Squamous cell carcinoma of the head and neck, nasopharyngeal cancer, or salivary gland cancer * COHORT II: Solid tumor to the head and neck amenable to palliative treatment, including but not limited to squamous cell carcinoma, adenocarcinoma, sarcoma, melanoma, NK/T lymphoma, poorly differentiated thyroid cancer, and anaplastic thyroid cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Ability to understand and the willingness to sign a written informed consent document
  • For patients undergoing magnetic resonance imaging (MRI) sim, participants must have adequate renal function to tolerate intravenous gadolinium contrast injection (estimated glomerular filtration rate >= 45 mL/min/1.73 m^2 prior to initial scan and estimated glomerular filtration rate >= 30 mL/min/1.73 m^2 for subsequent scans)
  • COHORT I: History of radiation to the head and neck area (defined as above the clavicles) greater than 6 months previous
  • COHORT I: Pathologically proven recurrent disease or a second primary (squamous cell carcinoma of the head and neck, nasopharyngeal cancer, or salivary gland cancer) within the head and neck region, deemed to be unresectable or resected with gross residual disease remaining or microscopically positive margins defined as closer than 5 mm (determined by either operative/pathology report or postsurgical imaging)
  • COHORT I: No significant contraindications to cisplatinum chemotherapy (significant hearing loss, renal dysfunction or neuropathy)
  • COHORT I: Leukocytes >= 3,000/mcL
  • COHORT I: Absolute neutrophil count >= 1,500/mcL
  • COHORT I: Platelets >= 100,000/mcL
  • COHORT I: Total bilirubin within normal institutional limits
  • COHORT I: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
  • COHORT I: Creatinine < 2 x upper limit of normal (ULN) or creatinine clearance >= 45 mL/min/1.73 m^2 for subjects with creatinine levels above institutional normal
  • COHORT II: Pathologically proven solid tumor in the head and neck that are amenable to palliative treatment
  • COHORT II: Measurable disease within the head and neck region, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with neck computed tomography (CT) scan or MRI

Exclusion Criteria

  • SBRT or hypofractionated IMRT target size > 10 cm in maximum diameter (or greater than 100 cc in volume)
  • Participants may not be receiving any other study agents
  • Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation, breastfeeding should be discontinued if the mother is treated with radiation
  • Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy are ineligible because of the potential for interaction between conventional radiotherapy, SBRT, hypofractionated IMRT and antiretroviral medications. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated
  • Patients who are planned to receive the following medications concurrent with radiation: granulocyte stimulating factor (G-CSF), bevacizumab, cyclosporine, anti-tumor necrosis factor agents, amifostine
  • For patients undergoing MRI sim- unable to undergo magnetic resonance imaging (MRI) due to any of the following: * Presence of MRI-incompatible metal material or devices in the human body * Severe claustrophobia * MRI-incompatible pacemaker or defibrillator * Insulin pump * Aneurysm clip * Artificial heart valve * Cochlear implant * Shrapnel or gunshot injury * Cataract surgery with implant unsafe for MRI
  • For MRI involving contrast, history of allergic reactions attributed to gadolinium-based IV contrast

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Contact: Jonathan Daniel Schoenfeld
Phone: 617-632-3591
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Jonathan Daniel Schoenfeld
Phone: 617-632-3591

PRIMARY OBJECTIVE:

I. To evaluate the safety and tolerability of stereotactic or hypofractionated treatments in the head and neck.

SECONDARY OBJECTIVES:

I. To determine the 1-year local control rate.

II. To determine the 1-year regional control rate.

III. To determine the 1-year progression free survival (cohort 1).

IV. To investigate immune responses engendered by stereotactic treatment.

V. Determination of the maximum tolerated dose (MTD) and dose-limiting toxicities of stereotactic treatment or hypofractionated boost for: 1) patients who have received prior radiation in the head and neck and currently have gross unresectable disease or microscopic positive margins; 2) patients amenable to palliative treatment with targetable lesions within the head and neck.

VI. To investigate changes in patient reported quality of life after treatment using the validated University of Washington Quality of Life Questionnaire version 4 (UW-QOL v4), administered at baseline, and 1, 2, 3, 6, 9 and 12 months following radiation.

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment cohorts.

COHORT I: Patients receive cisplatin intravenously (IV) over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo intensity-modulated radiation therapy (IMRT) 5 days a week (Monday-Friday) for 6 weeks. After 6 weeks, patients undergo hypofractionated IMRT once weekly for 2 weeks in the absence of disease progression or unacceptable toxicity.

COHORT II: Patients undergo stereotactic body radiation therapy 5 treatments over 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 week, 4 weeks, 2 and 3 months, and then every 3 months for 3 years from study enrollment.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Jonathan Daniel Schoenfeld

  • Primary ID 15-183
  • Secondary IDs NCI-2015-01833
  • Clinicaltrials.gov ID NCT02474368