Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer

  • End date
    May 31, 2023
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 4 October 2022
tumor cells
intensity-modulated radiation therapy


This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. 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. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.



I. To compare the 2-year rate of Common Terminology Criteria for Adverse Events (CTCAE)-4.0 grade 3 or higher toxicity at 2 years between the two treatment arms.


I. To compare the 2-year locoregional failure free survival (LFFS) in patients being treated with reirradiation with either stereotactic ablative radiotherapy (SBRT) versus intensity modulated radiation therapy/intensity modulated proton therapy (IMRT/IMPT).

II. To determine if there is any difference in local control, progression-free survival, and overall survival between the two arms.

III. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0 and Performance Status Scale-HN (Head and Neck).

IV. To compare patient reported outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy (FACT)-HN, ACT-HN Symptom Index (FACT-HNSI), MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), for skull base only, Anterior Skull BASE Questionnaire (ASBQ), for skull base only, Brief Fatigue Inventory (BFI), Telephone Interview for Cognitive Status (TICS), Performance Status Scale For Head and Neck Cancer Patients (PSS-HN), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem version (V)2.0 (WPAI:SHP), and University of Michigan Xerostomia-Related Quality of Life Scale, Xerostomia and Health Questionnaire (European Quality of Life Five Dimension Three Level [EQ-5D-3L]).

V. Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. VI. Compare cost-benefit economic analysis of treatment. VII. Perform dosimetric analysis and compare correlates of critical structures.


I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but may have dropped out of the study for other reasons after being randomized to; or were denied insurance coverage for the treatment arm she/he was randomized.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients undergo SBRT every other day for a total of 5 treatments.

GROUP II: Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.

After completion of study treatment, patients are followed up at 2-3 months, every 3 months for 1 year, and then every 3-4 months for up to 2 years.

Condition Recurrent Head and Neck Carcinoma
Treatment SBRT, Questionnaires, intensity-modulated radiation therapy, stereotactic body radiation therapy, Proton Radiation, IMRT/IMPT
Clinical Study IdentifierNCT03164460
SponsorM.D. Anderson Cancer Center
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
Not eligible for surgery for recurrence or poor surgical candidate
Gross disease apparent on imaging (magnetic resonance imaging [MRI] or computed tomography [CT])
-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
Negative pregnancy test for women of child bearing potential

Exclusion Criteria

Patients who are pregnant or breast feeding
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to
a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
b) No myocardial infarction within 3 months of registration
Widely metastatic disease (oligometastatic disease acceptable)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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