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

Primary Purpose

Endometrial Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Conventional Fractionation

Hypofractionation

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring endometrial cancer, uterine cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Royal Victoria Hospital
London Regional Cancer Program
Credit Valley Hospital
Sunnybrook Health Sciences CentreRecruiting
Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Fractionation Pelvic Radiation

Stereotactic Hypofractionated Radiation

Arm Description

Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol.

Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Local- regional failure

To compare presence of tumour through physical exam or radiologic imaging between hypofractionated treatment and conventional fractionation.

Disease-free survival

To compare disease-free survival of hypofractionated treatment and conventional fractionation

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.

Correlation of GU toxicity, EORTC, and EPIC

To measure correlations between GU toxicity and EORTC questionnaire versus GU toxicity and EPIC questionnaire.

Full Information

NCT ID

NCT04890912

First Posted

May 5, 2021

Last Updated

October 22, 2021

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04890912

Brief Title

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II

Acronym

SPARTACUSII

Official Title

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 15, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sunnybrook Health Sciences Centre

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

Keywords

endometrial cancer, uterine cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional Fractionation Pelvic Radiation

Arm Type

Active Comparator

Arm Description

Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol.

Arm Title

Stereotactic Hypofractionated Radiation

Arm Type

Experimental

Arm Description

Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.

Intervention Type

Radiation

Intervention Name(s)

Conventional Fractionation

Intervention Description

Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.

Intervention Type

Radiation

Intervention Name(s)

Hypofractionation

Intervention Description

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 Measure Information:

Title

Acute bowel toxicity

Description

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.

Time Frame

Baseline to 2 years following RT completion

Secondary Outcome Measure Information:

Title

Acute bowel toxicities

Description

Time Frame

Baseline to 2 years following RT completion

Title

Acute urinary toxicities through CTCAE

Description

Time Frame

Baseline to 2 years following RT completion

Title

Acute urinary toxicities through EPIC

Description

To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for uterine cancer as measured by EPIC.

Time Frame

Baseline to 2 years following RT completion

Title

Local- regional failure

Description

To compare presence of tumour through physical exam or radiologic imaging between hypofractionated treatment and conventional fractionation.

Time Frame

Baseline to 2 years following RT completion

Title

Disease-free survival

Description

To compare disease-free survival of hypofractionated treatment and conventional fractionation

Time Frame

Baseline to 2 years following RT completion

Title

Quality of life using EORTC QLQ-30 and endometrial module (EN-24)

Description

Time Frame

Baseline to 2 years following RT completion

Title

Correlation of GU toxicity, EORTC, and EPIC

Description

To measure correlations between GU toxicity and EORTC questionnaire versus GU toxicity and EPIC questionnaire.

Time Frame

Baseline to 2 years following RT completion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anika Mohan

Phone

416-480-5000

Ext

89828

anika.mohan@sunnybrook.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Nithla Mohanathas

Phone

416-480-5000

Ext

85838

nithla.mohanathas@sunnybrook.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Leung, MD

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kathy Han, MD

Organizational Affiliation

Princess Margaret Cancer Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adam Gladwish, MD

Organizational Affiliation

Royal Victoria Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Victoria Hospital

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adam Gladwish, MD

gladwisha@rvh.on.ca

First Name & Middle Initial & Last Name & Degree

Adam Gladwish, MD

First Name & Middle Initial & Last Name & Degree

Julia Skliarenko, MD

Facility Name

London Regional Cancer Program

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David D'Souza, MD

david.dsouza@lhsc.on.ca

First Name & Middle Initial & Last Name & Degree

David D'Souza, MD

First Name & Middle Initial & Last Name & Degree

Lucas Mendez, MD

First Name & Middle Initial & Last Name & Degree

Vikram Velker, MD

Facility Name

Credit Valley Hospital

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2N1

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jasper Yuen, MD

jyuen@cvh.on.ca

First Name & Middle Initial & Last Name & Degree

Jasper Yuen, MD

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anika Mohan

anika.mohan@sunnybrook.ca

First Name & Middle Initial & Last Name & Degree

Eric Leung, MD

First Name & Middle Initial & Last Name & Degree

Elizabeth Barnes, MD

First Name & Middle Initial & Last Name & Degree

Amandeep Taggar, MD

First Name & Middle Initial & Last Name & Degree

Melanie Davidson, MD

First Name & Middle Initial & Last Name & Degree

Andrew Loblaw, MD

First Name & Middle Initial & Last Name & Degree

Elysia Donovan, MD

First Name & Middle Initial & Last Name & Degree

Patrick Cheung, MD

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C1

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathy Han, MD

kathy.han@rmp.uhn.ca

First Name & Middle Initial & Last Name & Degree

Kathy Han, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II

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