MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer

Sponsor
Radboud University Medical Center
Study ID
NCT07514325
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 — RADIATION
    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).

Study Details

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.

Key Dates

First listed
Apr 7, 2026
Start date
May 1, 2026
Status verified
Nov 2025
Primary completion
Jun 1, 2028
Completion
Mar 1, 2033

Study Design

Enrollment
61 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional arm
    MR-guided stereotactic adaptive radiotherapy

Primary Outcome Measure

Acute gastrointestinal and genitourinary toxicity (within 3 months after start of treatment) [ Time Frame: 5 years after end of treatment ]

Central Contacts

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