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Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II (SPARTACUSII Trial)
N/A
Waitlist Available
Led By Kathy Han, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 years following rt completion
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new radiation treatment for uterine cancer patients who have had surgery. The treatment aims to be just as effective with fewer side effects and a shorter treatment duration.
Eligible Conditions
- Endometrial Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 years following rt completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 years following rt completion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute bowel toxicity
Secondary study objectives
Acute bowel toxicities
Acute urinary toxicities through CTCAE
Acute urinary toxicities through EPIC
+4 moreSide effects data
From 2023 Phase 2 trial • 88 Patients • NCT0278369091%
Dermatitis radiation
66%
Skin hyperpigmentation
34%
Joint range of motion decreased
30%
Non-cardiac chest pain
27%
Lymphedema
23%
Edema limbs
18%
Telangiestasia
18%
Esophagitis
16%
Breast infection
16%
Superficial soft tissue fibrosis
16%
Fibrosis deep connective tissue
5%
Seroma
2%
Brachial plexopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hypofractionation
Conventional Fractionation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Hypofractionated RadiationExperimental Treatment1 Intervention
Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.
Group II: Conventional Fractionation Pelvic RadiationActive Control1 Intervention
Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionation
2017
Completed Phase 2
~550
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
680 Previous Clinical Trials
1,565,816 Total Patients Enrolled
2 Trials studying Endometrial Cancer
45 Patients Enrolled for Endometrial Cancer
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Credit Valley HospitalOTHER
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London Regional Cancer Program, CanadaOTHER
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1,228 Total Patients Enrolled
Kathy Han, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
130 Total Patients Enrolled
Eric Leung, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
544 Total Patients Enrolled
1 Trials studying Endometrial Cancer
40 Patients Enrolled for Endometrial Cancer
Adam Gladwish, MDPrincipal InvestigatorRoyal Victoria Hospital