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Brief Title: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
Official Title: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial
Study ID: NCT04890912
Brief Summary: Adjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Royal Victoria Hospital, Barrie, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Credit Valley Hospital, Mississauga, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Name: Eric Leung, MD
Affiliation: Sunnybrook Health Sciences Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Kathy Han, MD
Affiliation: Princess Margaret Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Adam Gladwish, MD
Affiliation: Royal Victoria Hospital
Role: PRINCIPAL_INVESTIGATOR