Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorRutgers, The State University of New Jersey

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)

    Radiation

    Participants 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

30 Participants
are divided into 1 treatment group
Group A: Experimental: MR-guided Adaptive Pelvic IMRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Within 90 days after completion of treatment

Secondary outcomes

1

Patient-Reported Quality of Life

Assessed using the EORTC QLQ-C30 to evaluate quality of life and symptom burden over time.

Time frame
Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
2

Patient Reported Quality of Life

Description: Assessed using the EN-24 questionnaire to evaluate quality of life and symptom burden over time.

Time frame
Time Frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
3

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.

Time frame
Up to 2 years after completion of treatment.

Other outcomes

Sponsors and contacts

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