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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
Sponsor:
Information provided by (Responsible Party):
Dr. Eric Leung, Sunnybrook Health Sciences Centre

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: It's a Phase I feasibility study, 5 fractions (hypofractionation)
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Cancer

Arm Intervention/treatment
Experimental: Hypofractionated Pelvic Radiation Radiation: SBRT
Patients will be planned with the aim of delivering 30 Gy in 5 fractions.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Disease-free survival [ Time Frame: Study activation through 2 years post-RT ]
    To document the disease-free survival of those treated with adjuvant SBRT

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed endometrial adenocarcinoma
  • Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:

    • Patient has serous, clear cell, carcinosarcoma or differentiated histologies.
    • Outer-half myometrial invasion and FIGO grade 1-2 OR
    • FIGO stage II - IIIC1.
  • Willing and able to give informed consent to participate in this clinical trial.
  • Age ≥18 years.
  • Are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.
  • Willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
  • Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.

Exclusion Criteria:

  • Has had prior pelvic radiotherapy.
  • Has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
  • Has a contraindication to iodinated CT contrast.
  • Has a hip prosthesis.

Information from the National Library of Medicine

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


Contacts
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Contact: Amanda Fonseca 416-480-5000 ext 89828 amanda.fonseca@sunnybrook.ca
Contact: Sasha Manohar 416-480-5000 ext 7387

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Amanda Fonseca       amanda.fonseca@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Eric Leung, MD Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Eric Leung, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04866394    
Other Study ID Numbers: SPARTACUS
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases