Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer (ADAPT-EC)

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Endometrial Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07643012

152601

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental: MR-guided Adaptive Pelvic IMRT

Experimental group

Description:

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.

Treatment:

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