Endometrioid AdenocarcinomaNCT04458597
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus.
A study testing Image-guided adjuvant pelvic radiotherapy in people with Endometrioid Adenocarcinoma and Serous Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrioid Adenocarcinoma, Serous Carcinoma, Clear Cell Carcinoma
- What is being tested?
- Image-guided adjuvant pelvic radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2020to 14 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, who have undergone hysterectomy for curative intent, with histologically confirmed endometrioid adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma
- Patient is a candidate for adjuvant 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 informed consent to participate in this clinical trial.
Show all 10Show fewer
- 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.
Who cannot join
- Patient has had prior pelvic radiotherapy.
- Patient has received neo-adjuvant systemic therapy
- 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 iodinated CT contrast.
- Patient has a hip prosthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus: A Phase 1 Pilot Study (SPARTACUS)
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.
- Conditions
- Endometrioid Adenocarcinoma, Serous Carcinoma, Clear Cell Carcinoma, Carcinosarcoma, Dedifferentiated Carcinoma
- Being tested
- Image-guided adjuvant pelvic radiotherapy
- Medical subject headings
- Carcinoma, Endometrioid, Cystadenocarcinoma, Serous, Adenocarcinoma, Clear Cell, Carcinosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-guided adjuvant pelvic radiotherapyRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 years post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start26 Aug 2020
- Primary completion2 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrioid AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David D'Souza, M.D., Principal investigator, London Regional Cancer Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458597
- Sponsor's protocol ID
- SPARTACUS
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus: A Phase 1 Pilot Study (SPARTACUS)
- ClinicalTrials.gov ID
- NCT04458597
- Acronym / sponsor ID
- SPARTACUS
- Conditions
- Endometrioid Adenocarcinoma, Serous Carcinoma, Clear Cell Carcinoma, Carcinosarcoma, Dedifferentiated Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients, who have undergone hysterectomy for curative intent, with histologically confirmed endometrioid adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma
- Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:
- Patient is willing and able to give informed consent 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.
Key exclusion criteria (5 listed)
- Patient has had prior pelvic radiotherapy.
- Patient has received neo-adjuvant systemic therapy
- 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 iodinated CT contrast.
- Patient has a hip prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-guided adjuvant pelvic radiotherapyImage-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. | Radiation | – |
Primary outcome
Assess the acute urinary and bowel toxicities
Time frame: Baseline to 2 years post-treatment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David D'Souza, M.D. principal investigator
London Regional Cancer Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-guided adjuvant pelvic radiotherapy in people with Endometrioid Adenocarcinoma and Serous Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the acute urinary and bowel toxicities (time frame: Baseline to 2 years post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.