Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS (SPARTACUS)
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|ClinicalTrials.gov Identifier: NCT04866394|
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. A secondary result of these technologic advances has been the increased utilization of hypofractionationed treatment protocols, since the combined ability to better visualize and precisely deliver radiation to target volumes has allowed radiation oncologists to leverage the therapeutic ratio toward higher target doses whilst maintaining safe doses to the pertinent organs-at-risk. The spectrum of hypofractionation ranges from what are considered moderate (ie. 2- 5 Gy / fraction) into the realm of what is more commonly referred to as stereotactic body (SBRT), generally >5 Gy / fraction. There is growing evidence demonstrating both safety and efficacy for SBRT. The investigators propose that these advantages are translatable to the adjuvant treatment of endometrial cancer.
The investigators submit that a prescription dose of 30 Gy in 5 fractions. Through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Radiation: SBRT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||It's a Phase I feasibility study, 5 fractions (hypofractionation)|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS): A Phase I/II Study (SPARTACUS)|
|Actual Study Start Date :||July 3, 2019|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2024|
|Experimental: Hypofractionated Pelvic Radiation||
Patients will be planned with the aim of delivering 30 Gy in 5 fractions.
- Acute toxicities [ Time Frame: Baseline to 12 weeks following RT completion ]To assess the acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
- Quality of life through EORTC QLQ-C30 and EN24 [ Time Frame: Study activation through 2 years post-RT ]To assess the effect of adjuvant SBRT treatment on acute and late patient reported health quality of life using EORTC questionnaires.
- Late toxicities [ Time Frame: 12 weeks post-RT to 2 years post-RT ]To assess the late urinary, bowel, and other toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
- Local-regional failure [ Time Frame: Study activation through 2 years post-RT ]To assess the local-regional failure of adjuvant SBRT treatment by observation of progression or persistence of disease.
- Disease-free survival [ Time Frame: Study activation through 2 years post-RT ]To document the disease-free survival of those treated with adjuvant SBRT
- Dosimetric feasibility [ Time Frame: Baseline to RT completion ]The number of patients eligible for enrollment at a 30Gy prescription dose based rigid dosimetric constraints, as compared to a 27.5 Gy treatment dose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866394
|Contact: Amanda Fonseca||416-480-5000 ext firstname.lastname@example.org|
|Contact: Sasha Manohar||416-480-5000 ext 7387|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Amanda Fonseca email@example.com|
|Principal Investigator:||Eric Leung, MD||Sunnybrook Health Sciences Centre|