POSE - POs Surgery Endometrial Cancer

NCT06394258 | Completed

• 1 other identifier: POSE2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (4)

• Dosimetric Feasibility of vaginal cuff SBRT

  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)

  through study completion, an average of 3 year

• Reproducibility of vaginal cuff SBRT

  Anatomical accuracy will be confirmed with image guided (CBCT) and online tracking will guarantee a limit of 2mm threshold

  Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time

• Inter/intra fractional target motion

  3D deviations recorded in CBCT images and electromagnetic recording

  during the 15 minutes of treatment delivery time

• Adverse Events

  Treatment related side effects based on CTCAE V3.0

  through study completion, an average of 5 years

Secondary Outcomes (5)

• Quality of life metrics

  through study completion, an average of 5 years

• Quality of life metrics

  through study completion, an average of 5 years

• Quality of life metrics

  through study completion, an average of 5 years

• Local control

  through study completion, an average of 5 years

• Distant Relapse

  through study completion, an average of 5 years

Study Arms (1)

SBRT to the vaginal cuff

EXPERIMENTAL

SBRT to the vaginal cuff

Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

Stereotactic body radiotherapy to the vaginal cuff with the aim to reproduce adjuvant high dose rate (HDR) brachytherapy dose distribution by means of external beam radiotherapy in patients operated for intermediate risk endometrial carcinoma

Also known as: Stereotactic ablative body radiotherapy (SABR)

SBRT to the vaginal cuff

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacao Champalimaud: lead

Study Sites (1)

Champalimaud Foundation

Lisbon, 1400-038, Portugal

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Carlo Greco

  Radiotherapy Director Unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: May 1, 2024
• Study Start: June 18, 2018
• Primary Completion: July 18, 2020
• Study Completion: October 8, 2021
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)