About this trial
To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma, or dedifferentiated histology).
Age
High-grade histology (grade 2-3)
Depth of myometrial invasion
Disqualifiers
Prior pelvic radiotherapy.
Contraindication to pelvic radiotherapy (e.g., active connective tissue disorder or inflammatory bowel disease).
Presence of a hip prosthesis that would compromise treatment planning or delivery.
Trial design
Single group
Treatments tested in this trial
MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)
RadiationParticipants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI guidance and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity
Defined as the number and proportion of participants experiencing grade ≥2 acute gastrointestinal or genitourinary treatment-related adverse events occurring within 90 days after completion of MR-guided adaptive pelvic IMRT, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, a standardized grading system for adverse events ranging from Grade 1 (mild) to Grade 5 (death related to adverse event)
Secondary outcomes
Patient-Reported Quality of Life
Assessed using the EORTC QLQ-C30 to evaluate quality of life and symptom burden over time.
Patient Reported Quality of Life
Description: Assessed using the EN-24 questionnaire to evaluate quality of life and symptom burden over time.
Disease-Free Survival
Disease-free survival will be measured as the time from completion of MR-guided adaptive pelvic IMRT to the first documented recurrence or death from any cause, whichever occurs first. Recurrence will be assessed by clinical evaluation and/or imaging according to institutional standards. Participants without recurrence or death will be censored at the date of last disease assessment.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: