About this trial
Endometrial cancer is a common gynaecological cancer. It is often diagnosed at an early stage. Surgery is the primary treatment. For patients with high-intermediate risk endometrial cancer, vaginal brachytherapy after surgery is the most common treatment option. This study aims to establish and compare rates of vaginal recurrence following various post surgery treatment options. In the standard arm of this study patients receive brachytherapy after surgery. In the experimental arm a test is carried out on the patient’s sample which was removed during surgery. This test determines the molecular profile of this patient’s endometrial cancer. Based on the results of this test, patients are split into different treatment groups and receive either brachytherapy, external beam radiation therapy or no additional treatment (observation). In this study patients are randomised on a 1:2 basis into the standard and experimental/molecular arm. In the molecular arm approximately 40% of patients will receive brachytherapy, 5% will receive external beam radiation therapy and 55% will be in the observation group.
External beam radiation therapy and brachytherapy are both forms of radiation treatment. External beam radiation is delivered over approximately 5 weeks and brachytherapy is delivered over approximately 2 weeks and is internal vaginal treatment. Patients who enrol on this study will be asked to complete quality of life questionnaires at various points throughout the study.
High-intermediate risk early stage endometrial cancer
Where’s this trial being run?
St Luke’s Radiation Oncology Network @ St James’s Hospital and St Luke’s Radiation Oncology Network @ St Luke’s Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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PORTEC4a: Randomised Phase III Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer
|Principal Investigator:||Dr Charles Gillham (St James's and St. Luke's Hospital)|
Cancer Trials Ireland (Ireland); Leiden University Medical Center (Overall)
Global: June 2016
Ireland: August 2019
|Global Recruitment Target:||500|
|Ireland Recruitment Target:||30 patients per year|