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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

Description

Uterine endometrial cancer poses a significant cause of morbidity and mortality as the sixth most common malignancy worldwide. The management of non-metastatic EC involves surgery, usually followed by adjuvant radiotherapy and/or adjuvant chemotherapy depending on the risk stratification. Radiation therapy can be delivered in the form of whole pelvic RT (WPRT), vaginal vault brachytherapy (VBT) or a combination of both techniques. Technological advancements now enable us to safely administer doses exceeding 2 Gy per fraction (hypofractionation), which can significantly reduce the treatment duration. By doing this, hypofractionation can save patient's time, reduce costs for the health system and reduce the load in radiotherapy units.

There is limited evidence assessing hypo fractionated regimens in gynecological malignancies, particularly in endometrial cancer. This protocol aims to assess the safety and efficacy of hypo fractionated adjuvant radiotherapy in endometrial cancer treated at the McGill University Health Centre (MUHC), reporting on acute toxicity, late toxicity, oncological outcomes, and quality of life.

Eligibility

Inclusion Criteria:

  • Patients 18 years of age or older, ECOG 0-2.
  • Newly diagnosed endometrial carcinoma, including endometrioid, serous, clear cell, carcinosarcoma, and dedifferentiated tumours.
  • FIGO 2009 stage I-IIIC1 are eligible. 20.
  • Patients will have had previous total hysterectomy + bilateral salpingo-oophorectomy + sentinel lymph node biopsy or pelvic nodal dissection, will be fully debulked (R0 resection).
  • Have an indication for adjuvant pelvic radiotherapy by the attending radiation oncology physician at tumour board discussion.

Exclusion Criteria:

  • ECOG 3 or higher.
  • Para-aortic nodal disease.
  • Non-standard surgery, evidence of residual disease after surgery.
  • Need of a radiotherapy field exceeding the whole pelvis.
  • Active inflammatory bowel disease.
  • Active scleroderma.
  • Previous cancer in the last 5 years (except non-melanoma skin cancer).
  • Patients with contraindication to CT contrast.
  • Inability to achieve dose constraints.
  • Inability to reproduce simulation positioning during treatment.

Study details
    Endometrial Cancer
    Endometrial Adenocarcinoma

NCT07871838

McGill University Health Centre/Research Institute of the McGill University Health Centre

21 October 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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