Recruiting

IMRT

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07643012

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07643012

Start date

Jun 9, 2026

Status verified date

May, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior pelvic radiotherapy.
2. Contraindication to pelvic radiotherapy (e.g., active connective tissue disorder or inflammatory bowel disease).
3. Presence of a hip prosthesis that would compromise treatment planning or delivery.

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Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: MR-guided Adaptive Pelvic IMRT

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.

Interventions

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

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 outcome measure

  • Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity [ Time Frame: Within 90 days after completion of treatment ]

Central Contacts and Locations

Central contacts

Lara Hathout, MD

732-235-2465Lh547@rutgers.edu

Locations

Rutgers Cancer Institut Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-06.