Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer

NCT07643012 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 152601
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer.

Conditions

Endometrial Cancer

Outcome Measures

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)

  Within 90 days after completion of treatment

Secondary Outcomes (3)

• Patient-Reported Quality of Life

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

• Patient Reported Quality of Life

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

• Disease-Free Survival

  Up to 2 years after completion of treatment.

Study Arms (1)

Experimental: MR-guided Adaptive Pelvic IMRT

EXPERIMENTAL

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 and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk. Vaginal brachytherapy may be administered following IMRT at the treating physician's discretion per institutional standards.

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

Interventions

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.

Experimental: MR-guided Adaptive Pelvic IMRT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma, or dedifferentiated histology).
• Indication for adjuvant pelvic radiotherapy (± vaginal brachytherapy) for HIR defined by the ASTRO guidelines and GOG-99(7, 9) :
• Age
• High-grade histology (grade 2-3)
• Depth of myometrial invasion
• LVSI
• Positive pelvic nodes
• Cervical stromal invasion
• Presence of poor prognostic molecular markers
• Age ≥18 years.
• Ability to provide informed consent.
• Eligible to receive adjuvant systemic therapy, if indicated, with a minimum 3-week interval between chemotherapy and radiotherapy.
• Willing and able to complete EORTC QLQ-C30 and EN-24 questionnaires in a validated language version.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institut Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lara M Hathout

  Rutgers University - Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Hathout, MD

CONTACT

732-235-2465; Lh547@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Rutgers Cancer Institute, Department of Radiation Oncology

Model Details: This is a prospective, single-arm, multi-center phase II pilot study within the RWJBarnabas Health system evaluating MR-guided IMRT, 30 Gy in 5 fractions, in patients with high-risk endometrial cancer. The study will enroll 30 patients to assess safety, feasibility, and preliminary efficacy of MR-linac-delivered SBRT.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)