Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
(SPARTACUSII Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byEric Leung, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

Stay on Your Current Meds

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Inclusion Criteria

Patient is a candidate for adjuvant pelvic radiation for uterine cancer (+/- vault brachytherapy), meeting one of the following conditions: High grade histology (including serous and clear cell) OR Outer-half myometrial invasion and International Federation of Gynecology and Obstetrics (FIGO) grade 1-2 OR FIGO stage II - III.

Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.

Age ≥18 years.

+2 more

Exclusion Criteria

You are currently planning to receive both chemotherapy and radiation therapy at the same time.

You cannot receive pelvic radiotherapy due to certain medical conditions like connective tissue disease or inflammatory bowel disease.

You have received radiation therapy to your pelvic area in the past.

Participant Groups

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.

Hypofractionation is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Hypofractionation for: