Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)

January 19, 2020 updated by: Dr. Yasir Alayed, King Saud University

Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 30 Gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

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

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Saud University Medical City
        • Contact:
        • Principal Investigator:
          • Yasir Alayed, MD

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient with histologically confirmed endometrial adenocarcinoma
  • Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: High grade histology OR Outer-half myometrial invasion with any risk factors OR FIGO stage II - IIIC1.
  • Age ≥18 years.
  • Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.

Exclusion Criteria:

  • Patient has had prior pelvic radiotherapy.
  • Patient has Type II endometrial cancer histology (ie. Serous, clear cell or carcinosarcoma).
  • Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
  • Patient has a contraindication to CT contrast.
  • Patient has a hip prosthesis.

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: SABR
Pelvic SABR for post-op endometrial cancer
Radiation: SABR
SABR to a dose of 30Gy/5 to the pelvis (vaginal and paravaginal tissues as well as regional lymph nodes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Treatment-Related Adverse Events
Time Frame: 3 months after accrual is completed
The number of participants with acute (<3 months) urinary and bowel treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria
3 months after accrual is completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Treatment-Related Adverse Events
Time Frame: 5 years after accrual is completed
The number of participants with late (>3 months) urinary and bowel treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria
5 years after accrual is completed
Disease Local-Regional Failure Rate
Time Frame: 5 years after accrual is completed
The rate of local-regional failure of the disease in participants after adjuvant SABR treatment in the setting of high-risk endometrial cancer.
5 years after accrual is completed
Quality of Life
Time Frame: 5 years after accrual is completed
The mean decrease in Quality of Life in participants after adjuvant SBRT treatment using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN-24 companion.
5 years after accrual is completed

Collaborators and Investigators

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

Sponsor

King Saud University

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)

January 16, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-19-4466

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

product manufactured in and exported from the U.S.

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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