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 on Radiation and Chemotherapy for Salivary Gland Cancer

Recruiting
18 years - 100 years
All
Phase 2/3
4 participants needed
1 Location

Brief description of study.

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: malignant,salivary gland tumor,cancer,malignancy,radiation,chemotherapy
  • Age: 18 years - 100 years
  • Gender: All

Individuals at least 18 years of age with Resected High-Risk Malignant Salivary Gland Tumors.

Individuals who have prior systemic chemotherapy or radition therapy for salivary gland malignancy will not be eligible.

Individuals with severe, active co-morbidity, or significant pre-existing hearing loss will not be eligible.

Women who are pregnant will not be eligible.

Updated on 19 Feb 2024. Study ID: 1910732389

This study investigates the effects of radiation and chemotherapy compared to radiation alone in treating salivary gland cancer. Salivary gland cancer affects the glands that produce saliva, and this study aims to find out which treatment is better at reducing the chance of the cancer returning.

Participants will undergo several procedures, including physical exams, blood tests, and imaging scans. They will be divided into two study arms: one receiving only radiation therapy and the other receiving radiation plus chemotherapy. The study will monitor participants' health through regular tests and evaluations.

  • Who can participate: Adults 18 years or older with resected high-risk malignant salivary gland tumors can participate. Those with previous chemotherapy or radiation for this cancer, severe co-morbidities, significant hearing loss, or who are pregnant are not eligible.
  • Study details: Participants will be randomly assigned to receive either radiation therapy alone or with chemotherapy. Radiation is given daily, while chemotherapy is weekly for 7 weeks. A placebo is not used in this study.

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