Clinical trial NCT06394258: POSE - POs Surgery Endometrial Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: Fundacao Champalimaud
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Endometrial Cancer adjuvant treatment: Exclusive fractionated radiosurgery 21 Gy/3 fractions (BED10 35,7 Gy) prescribed to 100% isodose at 5 mm from the mucosa surface and 150% isodose to the mucosa surface (BED10 64,675 Gy)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This phase I/II feasibility study of hypo-fractionated, image-guided Volumetric Modulated Arc Therapy (VMAT) Stereotactic Body Radiotherapy (SBRT) to the vaginal cuff aims to reproduce adjuvant High Dose Rate (HDR) brachytherapy dose distributions in patients operated for intermediate and high risk endometrial carcinoma. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time on-line tracking. Eligible patients will receive three SBRT sessions to a prescription dose of 7 Gy to the vaginal cuff (with 4 to 7 days interval). SBRT will start within 4 to 8 weeks post-hysterectomy. The study will enroll a total of 30 patients. After treatment, patients will be followed-up at 3 months (+/- 6 weeks), at 6 (+/- 6 weeks) and every 6 months (+/- 6 weeks) thereafter for a total of 2 years. The duration of accrual in the study will be up to 3 years. Toxicity and outcome will be compared to published data on the standard modality of care (HDR brachytherapy). Patients' quality of life measures will be collected with validated questionnaires at the baseline and during follow up. Recurrence rates and survival data will be reported.

Eligibility criteria: 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.

Primary outcomes:
measure: Dosimetric Feasibility of vaginal cuff SBRT
timeFrame: through study completion, an average of 3 year
measure: Reproducibility of vaginal cuff SBRT
timeFrame: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
measure: Inter/intra fractional target motion
timeFrame: during the 15 minutes of treatment delivery time
measure: Adverse Events
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Quality of life metrics
timeFrame: through study completion, an average of 5 years
measure: Quality of life metrics
timeFrame: through study completion, an average of 5 years
measure: Quality of life metrics
timeFrame: through study completion, an average of 5 years
measure: Local control
timeFrame: through study completion, an average of 5 years
measure: Distant Relapse
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Champalimaud Foundation
Study officials:
affiliation: Radiotherapy Director Unit
name: Carlo Greco
role: STUDY_DIRECTOR
References: