Adaptive Intensity-Modulated Radiation Therapy in Treating Patients with Head and Neck Cancer

Status: complete

This phase II trial studies the side effects and how well adaptive intensity-modulated radiation therapy works in treating patients with head and neck cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adaptive intensity-modulated radiation therapy may help patients with head and neck cancer by targeting tumors more accurately and reducing side effects of the radiation treatment.

Inclusion Criteria

Patients with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy
Karnofsky performance status >= 70%
Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
Patients must have the ability to understand and the willingness to sign a written consent form

Exclusion Criteria

Female patients who are pregnant or breast feeding
Patients who are not able to comply with study and/or follow up procedures
Patients who have received induction chemotherapy before radiation treatment
Patients who had prior head and neck radiation therapy
Patients who are enrolled in a national/international cooperative group trials
Patients with metastatic disease

PRIMARY OBJECTIVE:

I. To demonstrate that adaptive radiotherapy (ART) results in comparable locoregional control rates as compared to our historical controls in head and neck patients undergoing standard radiation therapy.

SECONDARY OBJECTIVES:

I. To evaluate the rates of acute and long-term toxicities (Common Terminology Criteria for Adverse Events version 4 [CTCAE, v.4]) during treatment and to correlate them with calculations of delivered dose where possible.

II. To correlate the magnetic resonance imaging (MRI) or computed tomography (CT) imaging parameter changes with the following outcomes: anatomic changes of salivary glands, dosimetric parameter changes of salivary glands and grade 3+ normal tissue toxicities.

III. To evaluate patients' quality of life through Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 35 (EORTC QLQ C30 and H&N 35), EuroQol 5D (EQ-5D) questionnaires.

EXPLORATORY OBJECTIVE:

I. To record the fluence (Watchdog technology) of the treatment beams after they have exited the patient for indicators of anatomic change that patients may experience during their radiotherapy (optional to the physician's discretion).

OUTLINE:

Patients undergo adaptive intensity-modulated radiation therapy (IMRT) over 15-45 minutes once daily (QD) 5 days per week for a total of 30-35 fractions with or without concurrent chemotherapy according to the current standard of care.

After completion of study treatment, patients are followed up at 4, 12, 24, and 36 months.

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Adaptive Intensity-Modulated Radiation Therapy in Treating Patients with Head and Neck Cancer

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