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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre • ClinicalTrials.gov ID: NCT07871838

Registry updated: 2026-10-13
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Description

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

Interventions

  • Hypo fractionated RT (Radiation)
    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

Eligibility criteria

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.

Conditions

Endometrial Cancer Endometrial Adenocarcinoma

Locations

  • McGill University Health Centre--Cedars Cancer Centre — Montreal, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record