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NOT YET RECRUITING
NCT07514325
NA

MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

Rationale: External beam radiotherapy (EBRT) is an important cornerstone in treatment to reduce locoregional relapse in high(-intermediate) risk endometrial cancer (EC) patients. MR-guided adaptive radiotherapy (MGART) allows for more accurate delivery of radiation beams to the patients by visualizing and correcting for interfraction motion, with subsequent reduction of safety margins around the radiotherapy plan. Objective: The MASTEC study will investigate the safety of hypofractionated MR-guided adaptive radiotherapy in five fractions for elective pelvic nodal and vaginal vault irradiation in endometrial cancer. Study design: Phase II multicentre intervention study Study population: Patients with endometrial cancer that receive adjuvant EBRT to the pelvic nodal areas and vaginal vault (with or without vaginal brachytherapy). Intervention (if applicable): MR-guided adaptive radiotherapy (MGART) with reduced PTV margins, including 5 times 6Gy to the vaginal vault and pelvic nodal areas, 2 times a week . Main study parameters/endpoints: The primary endpoint is acute gastrointestinal and genitourinary toxicity, scored by the Common Terminology Criteria Adverse Events version 6.0. Secondary endpoints are late gastrointestinal and genitourinary toxicity, quality of life and disease free survival; disease-specific survival; overall survival and metastasis-free survival.

Official title: MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer (MASTEC)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2026-05-01

Completion Date

2033-03-01

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

RADIATION

MR-guided adaptive radiotherapy (MGART) with reduced PTV margins, including 5 times 6Gy to the vaginal vault and pelvic nodal areas, 2 times a week

Patients will be treated with hypofractionated MR-guided adaptive radiotherapy up to 30Gy to the vaginal vault and pelvic nodal areas, contoured on T2W MRI and CT (slice thickness 3mm). Radiotherapy will not be performed on consecutive days. Radiotherapy will be performed by IMRT (7MV) on an MR-linac (Elekta Unity).