Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS

NCT04866394 | Unknown

• 1 other identifier: SPARTACUS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 weeks following RT completion

Secondary Outcomes (5)

• Quality of life through EORTC QLQ-C30 and EN24

  Study activation through 2 years post-RT

• Late toxicities

  12 weeks post-RT to 2 years post-RT

• Local-regional failure

  Study activation through 2 years post-RT

• Disease-free survival

  Study activation through 2 years post-RT

• Dosimetric feasibility

  Baseline to RT completion

Study Arms (1)

Hypofractionated Pelvic Radiation

EXPERIMENTAL

Radiation: SBRT

Interventions

SBRT RADIATION

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

Hypofractionated Pelvic Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 35420695 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Eric Leung, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It's a Phase I feasibility study, 5 fractions (hypofractionation)

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: April 29, 2021
• Study Start: July 3, 2019
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)