Clinical trial NCT04866394: Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS
Official title: Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS): A Phase I/II Study (SPARTACUS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It's a Phase I feasibility study, 5 fractions (hypofractionation)
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Acute toxicities
timeFrame: Baseline to 12 weeks following RT completion
Secondary outcomes:
measure: Quality of life through EORTC QLQ-C30 and EN24
timeFrame: Study activation through 2 years post-RT
measure: Late toxicities
timeFrame: 12 weeks post-RT to 2 years post-RT
measure: Local-regional failure
timeFrame: Study activation through 2 years post-RT
measure: Disease-free survival
timeFrame: Study activation through 2 years post-RT
measure: Dosimetric feasibility
timeFrame: Baseline to RT completion
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Eric Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.