Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07643012

Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Cancer Institut Jersey

New Brunswick, New Jersey, 08901, United States

Location status: Recruiting

Location contact

Lara Hathout

CONTACT

About this study

The purpose of this research study is to evaluate a new way of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment. If you take part in the research, you will receive radiation therapy using MR-guided imaging. This involves daily radiation treatments that may be adjusted based on imaging taken at each session (called adaptive radiotherapy). This approach is considered investigational because it is not yet a standard treatment for endometrial cancer. Your time in the research will take Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments due to the imaging and treatment planning performed on the same day.The purpose of this research study is to evaluate a new method of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of the treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment.

If you participate in this research, you will receive radiation therapy guided by MR imaging. This will involve daily radiation treatments that may be adjusted based on imaging taken at each session (known as adaptive radiotherapy). This approach is considered investigational as it is not yet a standard treatment for endometrial cancer.

Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments because imaging and treatment planning are performed on the same day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

-

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity

    Time frame: Within 90 days after completion of treatment

    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)

Secondary outcomes

  1. 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

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

  2. Patient Reported Quality of Life

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

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

  3. Disease-Free Survival

    Time frame: Up to 2 years after completion of treatment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lara Hathout, MD

CONTACT

[email protected]

732-235-2465

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study

Acronym: ADAPT-EC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 11, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.