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To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Quality of Life | Assessed using the EORTC QLQ-C30 to evaluate quality of life and symptom burden over time. | Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years |
| Patient Reported Quality of Life |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lara Hathout, MD | Contact | 732-235-2465 | Lh547@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lara M Hathout | Rutgers University - Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institut Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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.
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Description: Assessed using the EN-24 questionnaire 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 |
| 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. | Up to 2 years after completion of treatment. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |