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

  • STATUS
    Recruiting
  • participants needed
    4
Send
Updated on 19 February 2024

Summary

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.

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.

Details
Condition malignant,salivary gland tumor,cancer,malignancy,radiation,chemotherapy
Age 18years - 100years
Clinical Study IdentifierNCT01220583
Last Modified on19 February 2024

Eligibility

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.