MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 years or older with histologically proven carcinoma of the endometrium, treated with curative hysterectomy with or without bilateral salpingo-oophorectomy. All histologies may be included (endometrioid, clear cell carcinoma, de-/undifferentiated carcinoma, carcinosarcoma, other non-endometrioid)
FIGO IB grade 3 endometrioid carcinoma
FIGO stage II endometrioid carcinoma
FIGO stage IIIA-C1 endometrioid carcinoma
Disqualifiers
Contra-indications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrofobia
Presence of para-aortic lymph node metastases (FIGO stage IIIC2)
Prior pelvic radiotherapy
WHO performance score > 2
Trial design
Design model
Single group
Treatments tested in this trial
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
RadiationPatients 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).
Treatment groups
61 Participants
are divided into 1 treatment groupGroup A: Interventional armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute gastrointestinal and genitourinary toxicity (within 3 months after start of treatment)
1. Primary outcomes: Acute gastrointestinal toxicity: Maximum CTCAE v6.0 grade of GI toxicity within 90 days after treatment. Acute genitourinary toxicity: Maximum CTCAE v6.0 grade of GU toxicity within 90 days after treatment. 2. Secondary Outcomes Late gastrointestinal toxicity: Maximum CTCAE v6.0 grade between 90 days and 5 years after treatment. Late genitourinary toxicity: Maximum CTCAE v6.0 grade between 90 days and 5 years after treatment. Acute vaginal toxicity: Maximum CTCAE v6.0 grade within 90 days after treatment. Late vaginal toxicity: Maximum CTCAE v6.0 grade between 90 days and 5 years after treatment. Quality of life: EORTC QLQ-C30 and QLQ-EN24 scores at 6 months and annually up to 5 years. Locoregional disease-free survival: Time to locoregional recurrence or death. Distant disease-free survival: Time to distant metastasis or death. Overall survival: Time to death from any cause. Endometrial cancer-specific survival: Time to death due to endometrial cancer
Time frame
5 years after end of treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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