Purpose of this Study
This study is comparing two chemotherapy treatment plans for children and young adults with newly diagnosed intermediate risk rhabdomyosarcoma. Researchers want to learn whether a higher dose treatment given over a shorter time works as well as or better than a lower dose treatment with additional maintenance therapy given over a longer time, along with standard surgery and radiation.
Who Can Participate?
Eligibility
Participants may be able to join if they are 50 years old or younger and have a newly diagnosed type of soft tissue cancer called rhabdomyosarcoma. They cannot have an uncontrolled infection or another cancer that is being treated with chemotherapy or radiation. People who had a different cancer treated only with surgery may still be eligible.
Age Range
0-50
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is comparing a higher dose chemotherapy treatment given over a shorter period of time with a lower dose chemotherapy treatment given over a longer period of time that includes maintenance therapy. Researchers want to learn which approach works better and understand the benefits and risks of each treatment for patients with intermediate risk rhabdomyosarcoma.
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
ARST2531: A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients with Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma
Principal Investigator
Jessica
Sun
Protocol Number
PRO00120899
NCT ID
NCT07466316
Phase
III
Enrollment Status
Open to Enrollment