Safety, Efficacy and Quality of Life After Adjuvant Hypofractionated Radiotherapy for Endometrial Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Hypo fractionated RT: The patients will receive whole pelvic radiotherapy (WPRT) to a total dose of 28.5 Gy in 5 fractions in alternate days (BED 64.6 Gy), delivered by RapidArc. Vaginal brachytherapy boost, 6 Gy in 1 fraction, is allowed in patients with cervical stroma involvement

Study summary

Clinical experience with hypo fractionated radiotherapy to date has shown that it is a safe and effective way to treat many types of cancer. Hypo fractionation means that the patient receives a total of 5 radiation treatments every other day, rather than 25 treatments over 5 weeks.

The goal of this study is to find out how safe this special kind of radiation technique is for women with endometrial cancer, both right after the treatment and later on. We also want to see how well this treatment works in stopping the cancer from coming back and how it affects the patients' overall health and quality of life. The main question it aims to answer is:

How does this particular type of radiotherapy affect the patients in terms of short and long term side effects?

Participants will:

* Visit the clinic for a total of 15 times in 60 months for check ups
* Complete a total of 9 questionnaires throughout the 15 visits
* Have standard-of-care blood tests and imaging to monitor the cancer response to treatment

Eligibility

Primary outcome measure(s)

• Primary Outcome Measure — Three years
  Primary outcome: acute and late toxicity rates as measured by CTCAE v5.0. Toxicity will be considered acute if present up to 6 months after treatment and late if present beyond 6 months. Toxicity reports will be released at a median of 3 years of follow-up.

Trial sites (1)

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