Clinical trial · Interventional
POSE - POs Surgery Endometrial Cancer
POSE (POs Surgery Endometrial Cancer) - Phase I/II Study to Access SBRT as a Replacement for Brachytherapy in Intermediate and High Risk in Endometrial Cancer
- 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)
This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff in intermedium and high risk endometrial cancer. The primary endpoints are SBRT feasibility and dosimetrical reproducibility to HDR brachytherapy, inter/intra-fractional target motion assessment and toxicity rates. Secondary endpoints are quality of life measures, local control, disease free survival and overall survival.
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 |
|---|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT to the vaginal cuff
- description
- SBRT to the vaginal cuff
- interventionNames
- Radiation: Stereotactic body radiotherapy (SBRT)
Primary outcomes (4)
- measure
- Dosimetric Feasibility of vaginal cuff SBRT
- timeFrame
- through study completion, an average of 3 year
- description
- Fulfillment of protocol dosimetrical endpoints and constraints; physician assessment of complications (CTCAE V3.0) at specific time points during follow up (2 weeks, 3 and 6 months, then every 6 months until the end of the 3rd year, then annually until the end of the 5th year)
- measure
- Reproducibility of vaginal cuff SBRT
- timeFrame
- Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathology proven adenocarcinoma of the endometrium * National Comprehensive Cancer Network (NCCN) intermediate and high risk * Unstaged patients with \< 50% myometrium invasion; * Age ≥ 18; * World health organization - Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0-2 or Karnofsky performance status (KPS) ≥ 70; * Hemoglobin ≥ 8.0 g/dl; white blood cells count (WBC) ≥ 1,500/mm3 ; Platelets ≥ 40,000 cells/mm3 . * Signed informed consent Exclusion Criteria: * Evidence of post-surgical macroscopic residual disease; * Patients with anatomical incompatibility with online tracking device; * Psychiatric conditions; * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; * Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields; * Severe active co-morbidities.
References
Publications (0)
Data not yet available