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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Sunnybrook Health Sciences Centre

Collaborators

Princess Margaret Hospital, Canada
Royal Victoria Hospital, Canada
London Regional Cancer Program, Canada
Credit Valley Hospital

Investigators

  • 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)

July 15, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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