Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
NCT ID: NCT04890912
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-07-15
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Fractionation Pelvic Radiation
Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol.
Conventional Fractionation
Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
Stereotactic Hypofractionated Radiation
Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.
Hypofractionation
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.
Interventions
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Conventional Fractionation
Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
Hypofractionation
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
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Inclusion Criteria
2. 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.
3. Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.
4. Age ≥18 years.
5. Patient is willing and able to give informed consent to participate in this clinical trial.
Exclusion Criteria
2. Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
3. Patient planned for concurrent chemoradiation therapy.
18 Years
FEMALE
No
Sponsors
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Princess Margaret Hospital, Canada
OTHER
Royal Victoria Hospital, Canada
OTHER
Credit Valley Hospital
OTHER
London Regional Cancer Program, Canada
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Eric Leung
Principal Investigator
Principal Investigators
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Eric Leung, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Kathy Han, MD
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Adam Gladwish, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Victoria Hospital, Belfast
Locations
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Royal Victoria Hospital
Barrie, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPARTACUS II
Identifier Type: -
Identifier Source: org_study_id