POSE - POs Surgery Endometrial Cancer (POSE)

April 30, 2024 updated by: Inês Antunes, Fundacao Champalimaud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1400-038
        • Champalimaud Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT to the vaginal cuff
Radiation: Stereotactic body radiotherapy (SBRT)
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
Other Names:
  • Stereotactic ablative body radiotherapy (SABR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetric Feasibility of vaginal cuff SBRT
Time Frame: through study completion, an average of 3 year
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
Time Frame: Accuracy of treatment delivery will be measured during the 15 minutes of treatment delivery time
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
Time Frame: during the 15 minutes of treatment delivery time
3D deviations recorded in CBCT images and electromagnetic recording
during the 15 minutes of treatment delivery time
Adverse Events
Time Frame: through study completion, an average of 5 years
Treatment related side effects based on CTCAE V3.0
through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life metrics
Time Frame: through study completion, an average of 5 years
change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire C30
through study completion, an average of 5 years
Quality of life metrics
Time Frame: through study completion, an average of 5 years
change from baseline in European Organisation for Research and Treatment of Cancer quality of life questionnaire quality of life questionnaire N24
through study completion, an average of 5 years
Quality of life metrics
Time Frame: through study completion, an average of 5 years
scoring more than 12 points in Hospital Anxiety and Depression Scale (HADS)
through study completion, an average of 5 years
Local control
Time Frame: through study completion, an average of 5 years
Free from loco-regional relapse
through study completion, an average of 5 years
Distant Relapse
Time Frame: through study completion, an average of 5 years
Free from distant relapse
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacao Champalimaud

Investigators

  • Study Director: Carlo Greco, Radiotherapy Director Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Actual)

July 18, 2020

Study Completion (Actual)

October 8, 2021

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POSE2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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