Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
SPARTACUSII
1 other identifier
interventional
50
1 country
5
Brief Summary
Adjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 25, 2021
October 1, 2021
11 months
May 5, 2021
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute bowel toxicity
To compare the acute bowel toxicities associated with hypofractionated vs conventional adjuvant pelvic radiation as measured by the The Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
Baseline to 2 years following RT completion
Secondary Outcomes (7)
Acute bowel toxicities
Baseline to 2 years following RT completion
Acute urinary toxicities through CTCAE
Baseline to 2 years following RT completion
Acute urinary toxicities through EPIC
Baseline to 2 years following RT completion
Local- regional failure
Baseline to 2 years following RT completion
Disease-free survival
Baseline to 2 years following RT completion
- +2 more secondary outcomes
Study Arms (2)
Conventional Fractionation Pelvic Radiation
ACTIVE COMPARATORPatients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol.
Stereotactic Hypofractionated Radiation
EXPERIMENTALPatients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.
Interventions
Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
Dose prescribed is 30 Gy in 5 fractions (6 Gy per fraction) delivered every other day over 11 days. There will be a minimum of 36 hours and maximum of 96 hours between fractions. The entire course of treatment should be completed within no less than 10 days.
Eligibility Criteria
You may qualify if:
- Patient with histologically confirmed endometrial adenocarcinoma, serous or clear cell carcinoma.
- Patient is a candidate for adjuvant pelvic radiation for uterine cancer (+/- vault brachytherapy), meeting one of the following conditions:
- High grade histology (including serous and clear cell) OR Outer-half myometrial invasion and International Federation of Gynecology and Obstetrics (FIGO) grade 1-2 OR FIGO stage II - III.
- Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.
- Age ≥18 years.
- Patient is willing and able to give informed consent to participate in this clinical trial.
You may not qualify if:
- Patient has had prior pelvic radiotherapy.
- Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
- Patient planned for concurrent chemoradiation therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Princess Margaret Hospital, Canadacollaborator
- Royal Victoria Hospital, Canadacollaborator
- Credit Valley Hospitalcollaborator
- London Regional Cancer Program, Canadacollaborator
Study Sites (5)
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
London Regional Cancer Program
London, Ontario, N6A 5W9, Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Leung, MD
Sunnybrook Health Sciences Centre
- PRINCIPAL INVESTIGATOR
Kathy Han, MD
Princess Margaret Cancer Centre
- PRINCIPAL INVESTIGATOR
Adam Gladwish, MD
Royal Victoria Hospital, Belfast
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 18, 2021
Study Start
July 15, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2023
Last Updated
October 25, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share