ClinicalTrials.gg
CompletedNCT04458597Updated Aug 1, 2025

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.

An interventional study of Image-guided adjuvant pelvic radiotherapy in Endometrioid Adenocarcinoma, Serous Carcinoma and Clear Cell Carcinoma, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. Furthermore, there is growing evidence demonstrating both safety and efficacy for SBRT. We propose that these advantages are translatable to the adjuvant treatment of endometrial cancer. We submit that a prescription dose of 30 Gy in 5 fractions, which equates to a 2 Gy equivalent dose (i.e an EQD2) (α/β = 10 Gy) of 48 Gy, compares favorably to the EQD2 delivered standardly for adjuvant treatment (44.25 Gy via 45Gy/25Fx; 50 Gy at vaginal surface for vault brachytherapy) and therefore should be effective and safe dose in the adjuvant setting. Through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.

02

Conditions studied

  • Endometrioid Adenocarcinoma
  • Serous Carcinoma
  • Clear Cell Carcinoma
  • Carcinosarcoma
  • Dedifferentiated Carcinoma
03

In context

Carcinoma, Endometrioid

46 studies on the registry are indexed under Carcinoma, Endometrioid; 11 are open to participants now.

This study's enrollment of 23 is below the median of 79 across 36 interventional studies indexed under Carcinoma, Endometrioid.

Browse Carcinoma, Endometrioid studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients, who have undergone hysterectomy for curative intent, with confirmed endometrioid adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma
  • Patient is a candidate for pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:

    • High grade histology OR
    • Outer-half myometrial invasion and FIGO grade 1-2 OR
    • FIGO stage II - IIIC1 (all gross nodal disease must be resected)
  • Patient is willing and able to give to participate in this clinical trial.
  • 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. Adjuvant systemic therapy may be given before or after radiation treatment.
  • Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
  • Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.

Exclusion criteria

Exclusion Criteria:

  • Patient has had prior pelvic radiotherapy.
  • Patient has received systemic therapy
  • Patient has a to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
  • Patient has a contraindication to iodinated CT contrast.
  • Patient has a hip prosthesis.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Interventions

  • RadiationImage-guided adjuvant pelvic radiotherapy

    Image-guided adjuvant pelvic radiotherapy delivered at an SBRT prescription dose of 30 Gy in 5 fractions if feasible, well-tolerated and effective for the adjuvant treatment of high-risk endometrial cancer.

06

What researchers measure

Primary outcomes

  1. Assess the acute urinary and bowel toxicities

    Acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer will be assessed using the Common Terminology Criteria for Adverse Events.

    Time frame: Baseline to 2 years post-treatment.

07

Study locations

1 site
  • London Regional Cancer Program
    London, Ontario N6A 5W9, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2020 to primary completion in May 2024, 44 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2020
First posted
Jul 7, 2020
StartActual
Aug 26, 2020
Primary completionActual
May 2, 2024
CompletionActual
May 14, 2024
Last update
Aug 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04458597
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
Aug 26, 2020
Primary completion
May 2, 2024
Completion
May 14, 2024
Last update
Aug 1, 2025

Study contacts

David D'Souza, M.D.
principal investigator · London Regional Cancer Program

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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