SPARTACUS: Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04866394
Collaborator
(none)
40
1
1
57
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: SBRT
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
It's a Phase I feasibility study, 5 fractions (hypofractionation)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 :
Jul 3, 2019
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypofractionated Pelvic Radiation

Radiation: SBRT
Patients will be planned with the aim of delivering 30 Gy in 5 fractions.

Outcome Measures

Primary Outcome Measures

  1. Acute toxicities [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 [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 [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 [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 [Study activation through 2 years post-RT]

    To document the disease-free survival of those treated with adjuvant SBRT

  5. Dosimetric feasibility [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Eric Leung, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Eric Leung, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT04866394
Other Study ID Numbers:
  • SPARTACUS
First Posted:
Apr 29, 2021
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022