Endometrial CancerSPARTACUSIINCT04890912
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
A study testing Conventional Fractionation and Hypofractionation in people with Endometrial Cancer, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Conventional Fractionation and Hypofractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Jul 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Not yet recruiting
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Adam Gladwish, MD, gladwisha@rvh.on.ca
Adam Gladwish, MD
- Not yet recruiting
London Regional Cancer Program
London, Ontario, N6A 5W9
David D'Souza, MD, david.dsouza@lhsc.on.ca
David D'Souza, MD
- Not yet recruiting
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Jasper Yuen, MD, jyuen@cvh.on.ca
Jasper Yuen, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Anika Mohan, anika.mohan@sunnybrook.ca
Eric Leung, MD
- Not yet recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
Kathy Han, MD, kathy.han@rmp.uhn.ca
Kathy Han, MD
About this study
Official title: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial
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.
- Conditions
- Endometrial Cancer
- Being tested
- Conventional Fractionation, Hypofractionation
- Keywords
- endometrial cancer, uterine cancer
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional FractionationRadiation
Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
HypofractionationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Fractionation Pelvic Radiation | Active comparator | Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol. Receives: Radiation: Conventional Fractionation |
| Stereotactic Hypofractionated Radiation | Experimental | Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique. Receives: Radiation: Hypofractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 years following RT completion
Secondary outcomes (7)
Acute bowel toxicities
To compare the acute bowel toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for endometrial cancers using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.
Measured: Baseline to 2 years following RT completion
Acute urinary toxicities through CTCAE
To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for endometrial cancers using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.
Measured: Baseline to 2 years following RT completion
Acute urinary toxicities through EPIC
To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for uterine cancer as measured by EPIC.
Measured: Baseline to 2 years following RT completion
Local- regional failure
To compare presence of tumour through physical exam or radiologic imaging between hypofractionated treatment and conventional fractionation.
Measured: Baseline to 2 years following RT completion
Disease-free survival
To compare disease-free survival of hypofractionated treatment and conventional fractionation
Measured: Baseline to 2 years following RT completion
Quality of life using EORTC QLQ-30 and endometrial module (EN-24)
To compare the effect of hypofractionated treatment and conventional fractionation on quality of life using the using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN-24 companion.
Measured: Baseline to 2 years following RT completion
Correlation of GU toxicity, EORTC, and EPIC
To measure correlations between GU toxicity and EORTC questionnaire versus GU toxicity and EPIC questionnaire.
Measured: Baseline to 2 years following RT completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start15 Jul 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, Royal Victoria Hospital, Canada, Credit Valley Hospital, London Regional Cancer Program, Canada
- Responsible party
- Principal investigator, Dr. Eric Leung, Sunnybrook Health Sciences Centre
- Investigators
- Eric Leung, MD, Principal investigator, Sunnybrook Health Sciences CentreKathy Han, MD, Principal investigator, Princess Margaret Cancer CentreAdam Gladwish, MD, Principal investigator, Royal Victoria Hospital, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890912
- Sponsor's protocol ID
- SPARTACUS II
- Acronym
- SPARTACUSII
- Status last verified
- Oct 2021
- First submitted
- 5 May 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04890912
- Acronym / sponsor ID
- SPARTACUSII / SPARTACUS II
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, uterine cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, Royal Victoria Hospital, Canada, Credit Valley Hospital, London Regional Cancer Program, Canada
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Fractionation Pelvic Radiation | Active comparator | Radiation: Conventional FractionationPatients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol. |
| Stereotactic Hypofractionated Radiation | Experimental | Radiation: HypofractionationPatients randomized to hypofractionation will be treated the stereotactic hypofractionated technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional FractionationDose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks. | Radiation | Conventional Fractionation Pelvic Radiation |
| HypofractionationDose 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. | Radiation | Stereotactic Hypofractionated Radiation |
Primary outcome
Acute bowel toxicity
Time frame: Baseline to 2 years following RT completion
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.
7 secondary outcomes
Acute bowel toxicities
Time frame: Baseline to 2 years following RT completion
Acute urinary toxicities through CTCAE
Time frame: Baseline to 2 years following RT completion
Acute urinary toxicities through EPIC
Time frame: Baseline to 2 years following RT completion
Local- regional failure
Time frame: Baseline to 2 years following RT completion
Disease-free survival
Time frame: Baseline to 2 years following RT completion
Quality of life using EORTC QLQ-30 and endometrial module (EN-24)
Time frame: Baseline to 2 years following RT completion
Correlation of GU toxicity, EORTC, and EPIC
Time frame: Baseline to 2 years following RT completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Leung, MD principal investigator
Sunnybrook Health Sciences Centre
Kathy Han, MD principal investigator
Princess Margaret Cancer Centre
Adam Gladwish, MD principal investigator
Royal Victoria Hospital, Belfast
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Fractionation and Hypofractionation in people with Endometrial Cancer, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anika Mohan (416-480-5000 ext. 89828, anika.mohan@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute bowel toxicity (time frame: Baseline to 2 years following RT completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.