A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors

Study Overview

This study will compare the effects, good and/or bad, of radiation and chemotherapy to radiation alone in salivary gland cancer to find out which is better at reducing the chance that the cancer will come back.

Study Description

Participants will undergo screening prior to joining the study, to include: physical exam, chest CT scan or CT/PET scan, blood tests, dental evaluation, hearing test, evaluation of ability to carry out day to day activities, and urine pregnancy test (for women of childbearing potential).

Participants will then be randomly assigned to 1 of 2 groups: one will receive radiation therapy once a day Monday-Friday for 6-7 weeks, and the other will receive this treatment in addition to receiving a total of 7 chemotherapy treatments (once weekly for 7 weeks).

During weekly treatment, all participants will complete blood tests, and participants receiving chemotherapy will also complete a physical exam.

At the end of treatment, researchers will complete a physical exam and evaluation of ability to carry out day to day functions and any side effects. The same will be completed 3 months later, in addition to more blood tests.

At 6, 12, and 24 months after treatment, participants will complete a CT scan or MRI. Twice yearly for 4 years and once yearly thereafter, researchers will contact participants to evaluate their daily activities.


  • IRB Number: 1910732389
  • Research Study Identifier: NCT01220583
  • Principal Investigator: Greg Durm, MD

Recruitment Status

Open

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