Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II (SPARTACUSII)

October 22, 2021 updated by: Dr. Eric Leung, Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Not yet recruiting
        • Royal Victoria Hospital
        • Principal Investigator:
          • Adam Gladwish, MD
        • Contact:
        • Sub-Investigator:
          • Julia Skliarenko, MD
      • London, Ontario, Canada, N6A 5W9
        • Not yet recruiting
        • London Regional Cancer Program
        • Contact:
        • Sub-Investigator:
          • David D'Souza, MD
        • Sub-Investigator:
          • Vikram Velker, MD
      • Mississauga, Ontario, Canada, L5M 2N1
        • Not yet recruiting
        • Credit Valley Hospital
        • Contact:
        • Sub-Investigator:
          • Jasper Yuen, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Sub-Investigator:
          • Patrick Cheung, MD
        • Contact:
        • Principal Investigator:
          • Eric Leung, MD
        • Sub-Investigator:
          • Elizabeth Barnes, MD
        • Sub-Investigator:
          • Amandeep Taggar, MD
        • Sub-Investigator:
          • Melanie Davidson, MD
        • Sub-Investigator:
          • Andrew Loblaw, MD
        • Sub-Investigator:
          • Elysia Donovan, MD
      • Toronto, Ontario, Canada, M5G 2C1
        • Not yet recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Kathy Han, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patient with histologically confirmed endometrial adenocarcinoma, serous or clear cell carcinoma.

  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:

  1. Patient has had prior pelvic radiotherapy.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Radiation: Conventional Fractionation
Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.
Experimental: Stereotactic Hypofractionated Radiation
Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 2 years following RT completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute bowel toxicities
Time Frame: Baseline to 2 years following RT completion
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.
Baseline to 2 years following RT completion
Acute urinary toxicities through CTCAE
Time Frame: Baseline to 2 years following RT completion
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.
Baseline to 2 years following RT completion
Acute urinary toxicities through EPIC
Time Frame: Baseline to 2 years following RT completion
To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for uterine cancer as measured by EPIC.
Baseline to 2 years following RT completion
Local- regional failure
Time Frame: Baseline to 2 years following RT completion
To compare presence of tumour through physical exam or radiologic imaging between hypofractionated treatment and conventional fractionation.
Baseline to 2 years following RT completion
Disease-free survival
Time Frame: Baseline to 2 years following RT completion
To compare disease-free survival of hypofractionated treatment and conventional fractionation
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
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.
Baseline to 2 years following RT completion
Correlation of GU toxicity, EORTC, and EPIC
Time Frame: Baseline to 2 years following RT completion
To measure correlations between GU toxicity and EORTC questionnaire versus GU toxicity and EPIC questionnaire.
Baseline to 2 years following RT completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Princess Margaret Hospital, Canada
Royal Victoria Hospital, Canada
London Regional Cancer Program, Canada
Credit Valley Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathy Han, MD, Princess Margaret Cancer Centre
  • Principal Investigator: Eric Leung, MD, Sunnybrook Health Sciences Centre
  • Principal Investigator: Adam Gladwish, MD, Royal Victoria Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPARTACUS II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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