⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for POSE - POs Surgery Endometrial Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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 ID: NCT06394258

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Champalimaud Foundation, Lisboa, , Portugal

Contact Details

Name: Carlo Greco

Affiliation: Radiotherapy Director Unit

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: