Back to resultsSIGNAL During a COVID-19 Pandemic
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring radiation therapy, radiotherapy, breast cancer, SBRT, neoadjuvant radiation, hypofractionation, stereotactic, preoperative
Eligibility Criteria
Inclusion Criteria:
- Female sex
- Age ≥ 50 years old
- Postmenopausal
- Tumor size < 3cm on pre-treatment imaging
- Any grade of disease, estrogen receptor (ER) positive, HER2 negative
- Unicentric/unifocal disease
- Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) .
- Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound).
- Surgical expectation that a > 2mm margin can be obtained.
- Lesion is 1 cm or greater from the skin surface.
- Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.
Exclusion Criteria:
- Male sex
- Under 50 years of age
- Previous RT to the same breast
- HER2 positive disease
- Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
- Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
- Distant metastases
- Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
- Prior non-hormonal therapy or radiation therapy for the current breast cancer
- Patients with Paget's disease of the nipple.
- Skin involvement, regardless of tumor size.
- Patients with a breast technically unsatisfactory for radiation therapy.
- Inability to lie prone with arms raised above head for extended periods of time.
- Patients not appropriate for BCS due to expectation of poor cosmetic result, even without RT
- Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)
- Inability or unwillingness to provide informed consent.
- Any other malignancy at any site (except non-melanomatous skin cancer) < 5 years prior to study enrollment
- Patients who are pregnant or lactating
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single fraction radiotherapy
Arm Description
Single fraction of 21 Gy stereotactic radiation therapy delivered to a single malignant lesion of the breast prior to any other treatment for breast cancer.
Outcomes
Primary Outcome Measures
Pathologic complete response (pCR)
To evaluate whether a pathologic complete response can be achieved when radiotherapy is delivered in a single 21 Gy fraction, establishing whether tumour response has a linear function with time in the context of delayed surgery. Pathologic complete response will be treated as a dichotomous variable (yes/no). Results will be stratified based on whether patients were also placed on neoadjuvant hormone treatment.
Feasibility of SBRT during a pandemic
To demonstrate feasibility of treating early stage breast cancer patients with a single 21 Gy fraction during the COVID-19 pandemic. This will be measured by accrual rate and the number of patients that can be treated during this pandemic.
Secondary Outcome Measures
Radiation toxicity
A secondary objective is to evaluate toxicity resulting from delivering radiation therapy in this manner. Toxicity will be evaluated using the CTCAE grading system.
Cosmesis
A secondary objective is to evaluate breast cosmesis resulting from delivery of radiation therapy in this manner. Cosmesis will be evaluated using the Modified Harvard-Harris Scale.
Full Information
NCT ID
NCT05037019
First Posted
May 5, 2020
Last Updated
May 10, 2022
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05037019
Brief Title
SIGNAL During a COVID-19 Pandemic
Official Title
Single Fraction Preoperative Radiation as a Strategy for Local Control of Breast Cancer During a COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Surgery wait times during the COVID-19 pandemic were eventually reduced to pre-pandemic wait times. This study became irrelevant.
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. However, the COVID-19 pandemic has necessitated changes in the way breast cancer is treated in order to reduce contact between individuals, reduce spread of the novel coronavirus, and lessen the impact on health care resources. As elective surgeries are being cancelled, current pandemic guidelines recommend that patients be started on hormone treatment while waiting for surgeries to be re-instated. Only after this surgery occurs will patients receive radiation treatment, dramatically extending the time between diagnosis and end of treatment. Emergency pandemic guidelines in the UK and other countries recommend 5 fractions of pre-operative radiation therapy where appropriate. Based on previous work in the SIGNAL 1.0 and SIGNAL 2.0 clinical trials, the investigators are proposing treating patients with early stage breast cancers with one single fraction of stereotactic neoadjuvant radiation during the pre-operative waiting period. This will allow patients to complete radiation therapy upfront while reducing the number of patient visits to hospital. This will also allow investigators to evaluate the ability of single-fraction targeted radiation to induce a pathologic complete response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
radiation therapy, radiotherapy, breast cancer, SBRT, neoadjuvant radiation, hypofractionation, stereotactic, preoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single fraction radiotherapy
Arm Type
Experimental
Arm Description
Single fraction of 21 Gy stereotactic radiation therapy delivered to a single malignant lesion of the breast prior to any other treatment for breast cancer.
Intervention Type
Procedure
Intervention Name(s)
Radiation therapy
Other Intervention Name(s)
Radiotherapy, Stereotactic body radiation therapy (SBRT)
Intervention Description
Women diagnosed with early stage breast cancer are given a single dose of stereotactic body radiation therapy (SBRT) prior to any other treatment in the context of delayed lumpectomy due to the COVID-19 pandemic.
Primary Outcome Measure Information:
Title
Pathologic complete response (pCR)
Description
To evaluate whether a pathologic complete response can be achieved when radiotherapy is delivered in a single 21 Gy fraction, establishing whether tumour response has a linear function with time in the context of delayed surgery. Pathologic complete response will be treated as a dichotomous variable (yes/no). Results will be stratified based on whether patients were also placed on neoadjuvant hormone treatment.
Time Frame
1 year
Title
Feasibility of SBRT during a pandemic
Description
To demonstrate feasibility of treating early stage breast cancer patients with a single 21 Gy fraction during the COVID-19 pandemic. This will be measured by accrual rate and the number of patients that can be treated during this pandemic.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Radiation toxicity
Description
A secondary objective is to evaluate toxicity resulting from delivering radiation therapy in this manner. Toxicity will be evaluated using the CTCAE grading system.
Time Frame
1.5 years
Title
Cosmesis
Description
A secondary objective is to evaluate breast cosmesis resulting from delivery of radiation therapy in this manner. Cosmesis will be evaluated using the Modified Harvard-Harris Scale.
Time Frame
1.5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female sex
Age ≥ 50 years old
Postmenopausal
Tumor size < 3cm on pre-treatment imaging
Any grade of disease, estrogen receptor (ER) positive, HER2 negative
Unicentric/unifocal disease
Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) .
Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound).
Surgical expectation that a > 2mm margin can be obtained.
Lesion is 1 cm or greater from the skin surface.
Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.
Exclusion Criteria:
Male sex
Under 50 years of age
Previous RT to the same breast
HER2 positive disease
Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
Distant metastases
Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
Prior non-hormonal therapy or radiation therapy for the current breast cancer
Patients with Paget's disease of the nipple.
Skin involvement, regardless of tumor size.
Patients with a breast technically unsatisfactory for radiation therapy.
Inability to lie prone with arms raised above head for extended periods of time.
Patients not appropriate for BCS due to expectation of poor cosmetic result, even without RT
Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)
Inability or unwillingness to provide informed consent.
Any other malignancy at any site (except non-melanomatous skin cancer) < 5 years prior to study enrollment
Patients who are pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muriel Brackstone, MD, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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SIGNAL During a COVID-19 Pandemic
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