Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS

NCT ID: NCT04866394

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hypofractionated Pelvic Radiation

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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

Interventions

SBRT

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Eric Leung

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Leung, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35420695 (View on PubMed)

Other Identifiers

SPARTACUS

Identifier Type: -

Identifier Source: org_study_id