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SBRT for Endometrial Cancer (SPARTACUS Trial)
N/A
Waitlist Available
Led By Eric Leung, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed endometrial adenocarcinoma
Age ≥18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post-rt to 2 years post-rt
Awards & highlights
SPARTACUS Trial Summary
This trial is investigating whether a new, more precise way of giving radiation therapy (RT) for endometrial cancer is just as effective but has fewer side effects than the current standard of care.
Who is the study for?
This trial is for adults over 18 with confirmed endometrial adenocarcinoma, including specific types like serous and clear cell. Candidates should have certain stages of cancer invasion or grade, be able to consent, speak English (or have questionnaires in their language), and can't have had prior pelvic radiotherapy or conditions that conflict with the treatment.Check my eligibility
What is being tested?
The trial tests Stereotactic Body Radiation Therapy (SBRT) as an adjuvant treatment for endometrial cancer. It aims to deliver a high dose of radiation precisely to the affected area while sparing healthy tissue, using advanced technology over five sessions totaling 30 Gy.See study design
What are the potential side effects?
While SBRT is designed to minimize side effects by targeting only cancer cells, potential side effects may include localized skin reactions, fatigue, mild discomfort at the treatment site, and possible short-term changes in bowel habits.
SPARTACUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with endometrial cancer.
Select...
I am 18 years old or older.
Select...
My cancer is either in the outer half of the uterus, grade 1-2, or stage II-IIIC1.
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My cancer is of a specific type (serous, clear cell, carcinosarcoma, or differentiated).
SPARTACUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks post-rt to 2 years post-rt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post-rt to 2 years post-rt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute toxicities
Secondary outcome measures
Disease-free survival
Dosimetric feasibility
Late toxicities
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
SPARTACUS Trial Design
1Treatment groups
Experimental Treatment
Group I: Hypofractionated Pelvic RadiationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,637 Total Patients Enrolled
2 Trials studying Endometrial Cancer
55 Patients Enrolled for Endometrial Cancer
Eric Leung, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
554 Total Patients Enrolled
1 Trials studying Endometrial Cancer
50 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with endometrial cancer.I am 18 years old or older.My cancer is either in the outer half of the uterus, grade 1-2, or stage II-IIIC1.My cancer is of a specific type (serous, clear cell, carcinosarcoma, or differentiated).I cannot receive pelvic radiotherapy due to a condition like inflammatory bowel disease.I am eligible for additional radiation therapy after my main treatment.My primary language is English or my language has the needed health questionnaires.I will have additional drug treatment for my cancer and there's a 3-week gap between my radiation and chemotherapy.You cannot have a certain type of contrast material used in CT scans.I have received radiation treatment in my pelvic area before.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofractionated Pelvic Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for this research project?
"According to information found on clinicaltrials.gov, this trial is not currently accepting participants and has not since May 4th 2022. Despite this inactivity, 311 other trials are actively recruiting patients right now."
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