Endometrial Cancer
Conditions
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.
Detailed 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.
Interventions
RADIATIONMR-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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Quality of Life | 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. |
| 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 | Description: Assessed using the EN-24 questionnaire to evaluate quality of life and symptom burden over time. |
| Disease-Free Survival | 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. |
Countries
United States
Contacts
CONTACTLara Hathout, MD
PRINCIPAL_INVESTIGATORLara M Hathout
Rutgers University - Cancer Institute
Outcome results
None listed