A Study to Compare the Toxic Effects and Disease Outcomes of Intensity-Modulated Proton Beam Therapy versus Intensity-Modulated Photon Therapy for the Treatment of Mouth and Throat Cancers

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-004913
    NCT ID: NCT01893307
    Sponsor Protocol Number: 2012-0825

About this study

The purpose of this study is to compare the toxic side effects and disease outcomes of intensity modulated photon therapy versus intensity modulated proton therapy. Participants may also receive chemotherapy along with radiation therapy.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Age >/= 18
  2. Histologically documented squamous cell carcinoma of the oropharynx (Stage III-IV A,B)
  3. Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization (ISH), immunohistochemistry (IHC) or genotyping testing) If you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing.
  4. Eastern Cooperative Oncology Group (ECOG) performance status= 0, 1, or 2
  5. Negative pregnancy test for women of child bearing potential

Exclusion Criteria:

  1. Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
  2. Pregnant or breast-feeding females
  3. 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 dysrrhythmia not controlled by pacer device. b) No myocardial infarction within 3 months of registration.
  4. Distant Metastases (Stage IV C, any T, any N and M1)
  5. Previous TransOral Robotic Surgery (TORS) to the oropharynx
  6. Unilateral Neck Radiation

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Foote, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20267893

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