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Hypofractionation for Endometrial Cancer (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 years following rt completion for reporting.

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 more

Side effects data

From 2023 Phase 2 trial • 88 Patients • NCT02783690

91%

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%

Fibrosis deep connective tissue

16%

Superficial soft tissue fibrosis

Seroma

Brachial plexopathy

100%

80%

60%

40%

20%

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

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