Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study.
Primary Objective:
1. To assess acute toxicity of moderately hypofractionated MR-guided adaptive pelvic IMRT using the Common Terminology Criteria for Adverse Events (CTCAE v6.0).
Secondary Objectives:
1. To report patient-reported outcomes using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN24 companion
2. To assess late toxicity of moderately hypofractionated MR-guided adaptive pelvic IMRT using the Common Terminology Criteria for Adverse Events (CTCAE v6.0).
3. To assess locoregional recurrence and disease-free survival.
4. To assess the feasibility and dosimetric advantages
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Rutgers University
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. -
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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