Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT).
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: 18 years — 90 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study
Overview
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
- Radiation 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 measures
- Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity [Time frame: Within 90 days after completion of treatment]
Secondary outcome measures (3)
- 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]
- 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]
- Disease-Free Survival [Time frame: Up to 2 years after completion of treatment.]
Eligibility criteria
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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rutgers Cancer Institut Jersey — New Brunswick
Identifiers
NCT: NCT07643012 · 152601