Clinical trial · Interventional
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study
NCT07643012CI-TRIAL-00116910ADAPT-ECrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety, tolerability, and preliminary efficacy of moderately hypofractionated (15-fraction) MR-guided adaptive pelvic IMRT in patients with endometrial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: MR-guided Adaptive Pelvic IMRT
- 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.
- interventionNames
- Radiation: MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)
Primary outcomes (1)
- measure
- Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity
- timeFrame
- Within 90 days after completion of treatment
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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. \-
References
Publications (0)
Data not yet available
No reference posted for this study.