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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04890912
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : October 25, 2021
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
Royal Victoria Hospital, Canada
Credit Valley Hospital
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
Dr. Eric Leung, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: Conventional Fractionation Radiation: Hypofractionation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Cancer

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Disease-free survival [ Time Frame: Baseline to 2 years following RT completion ]
    To compare disease-free survival of hypofractionated treatment and conventional fractionation

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890912


Contacts
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Contact: Anika Mohan 416-480-5000 ext 89828 anika.mohan@sunnybrook.ca
Contact: Nithla Mohanathas 416-480-5000 ext 85838 nithla.mohanathas@sunnybrook.ca

Locations
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Canada, Ontario
Royal Victoria Hospital Not yet recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Adam Gladwish, MD       gladwisha@rvh.on.ca   
Principal Investigator: Adam Gladwish, MD         
Sub-Investigator: Julia Skliarenko, MD         
London Regional Cancer Program Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: David D'Souza, MD       david.dsouza@lhsc.on.ca   
Sub-Investigator: David D'Souza, MD         
Sub-Investigator: Lucas Mendez, MD         
Sub-Investigator: Vikram Velker, MD         
Credit Valley Hospital Not yet recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Jasper Yuen, MD       jyuen@cvh.on.ca   
Sub-Investigator: Jasper Yuen, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Anika Mohan       anika.mohan@sunnybrook.ca   
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         
Sub-Investigator: Patrick Cheung, MD         
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Kathy Han, MD       kathy.han@rmp.uhn.ca   
Principal Investigator: Kathy Han, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Princess Margaret Hospital, Canada
Royal Victoria Hospital, Canada
Credit Valley Hospital
London Regional Cancer Program, Canada
Investigators
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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
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Responsible Party: Dr. Eric Leung, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04890912    
Other Study ID Numbers: SPARTACUS II
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Eric Leung, Sunnybrook Health Sciences Centre:
endometrial cancer
uterine cancer
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases