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Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS (SPARTACUS)

Primary Purpose

Endometrial Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SBRT
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated Pelvic Radiation

Arm Description

Outcomes

Primary Outcome Measures

Acute toxicities
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

Quality of life through EORTC QLQ-C30 and EN24
To assess the effect of adjuvant SBRT treatment on acute and late patient reported health quality of life using EORTC questionnaires.
Late toxicities
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
To assess the local-regional failure of adjuvant SBRT treatment by observation of progression or persistence of disease.
Disease-free survival
To document the disease-free survival of those treated with adjuvant SBRT
Dosimetric feasibility
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.

Full Information

First Posted
May 14, 2019
Last Updated
May 4, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04866394
Brief Title
Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS
Acronym
SPARTACUS
Official Title
Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS): A Phase I/II Study (SPARTACUS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It's a Phase I feasibility study, 5 fractions (hypofractionation)
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated Pelvic Radiation
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
Patients will be planned with the aim of delivering 30 Gy in 5 fractions.
Primary Outcome Measure Information:
Title
Acute toxicities
Description
To assess the acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
Time Frame
Baseline to 12 weeks following RT completion
Secondary Outcome Measure Information:
Title
Quality of life through EORTC QLQ-C30 and EN24
Description
To assess the effect of adjuvant SBRT treatment on acute and late patient reported health quality of life using EORTC questionnaires.
Time Frame
Study activation through 2 years post-RT
Title
Late toxicities
Description
To assess the late urinary, bowel, and other toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
Time Frame
12 weeks post-RT to 2 years post-RT
Title
Local-regional failure
Description
To assess the local-regional failure of adjuvant SBRT treatment by observation of progression or persistence of disease.
Time Frame
Study activation through 2 years post-RT
Title
Disease-free survival
Description
To document the disease-free survival of those treated with adjuvant SBRT
Time Frame
Study activation through 2 years post-RT
Title
Dosimetric feasibility
Description
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.
Time Frame
Baseline to RT completion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Leung, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35420695
Citation
Leung E, Gladwish AP, Davidson M, Taggar A, Velker V, Barnes E, Mendez L, Donovan E, Gien LT, Covens A, Vicus D, Kupets R, MacKay H, Han K, Cheung P, Zhang L, Loblaw A, D'Souza DP. Quality-of-Life Outcomes and Toxic Effects Among Patients With Cancers of the Uterus Treated With Stereotactic Pelvic Adjuvant Radiation Therapy: The SPARTACUS Phase 1/2 Nonrandomized Controlled Trial. JAMA Oncol. 2022 Jun 1;8(6):1-9. doi: 10.1001/jamaoncol.2022.0362.
Results Reference
derived

Learn more about this trial

Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS

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