Recruiting
Early Phase 1

Stereotactic Body Radiotherapy

Sponsor:

Juravinski Cancer Center

Code:

NCT03295916

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiotherapy

Study Details

Brief summary:

The purpose of this study is to evaluate feasibility to treat metachronous multi-site breast cancer oligometastasis with stereotactic body radiotherapy (SBRT) in patients on systemic therapy.

Conditions

Breast Cancer

Study ID

NCT03295916

Start date

Jan 1, 2018

Status verified date

Jan, 2020

Completion date

Apr 1, 2021

Anticipated

Primary completion date

Apr 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of newly metastatic breast cancer with a disease-free interval of at least six months from initial completion of primary breast cancer (stage I-III) treatment (including net-adjuvant or adjuvant chemotherapy, but excluding hormonal or targeted therapies).

Adequate definitive primary treatment is required, including partial or complete mastectomy, standard partial breast, whole breast or loco-regional radiotherapy, with or without hormonal therapy or chemotherapy. Note patients must be offered systemic therapy prior to radiotherapy, if deemed fit for treatment. Systemic therapy (including chemotherapy, hormonal therapy, or targeted therapy may have been initiated within the previous 12 months, or commence following SBRT. Alternatively patients may develop breast OM while on any adjuvant hormonal therapy provided at least six months have passed since definitive local treatment or chemotherapy;
2. No more than 12 months may have passed since diagnosis of OM disease;
3. Total burden of disease limited to 5 metastatic sites or less, and the size of each metastatic lesion must be less than 5 centimeters;
4. All lesions amenable to SBRT (lesions may overlap if treatable at discretion of Radiation Oncologist).

Exclusion Criteria:

1. Previous radiotherapy to same site or vicinity preventing definitive SBRT (eg. within 5 cm);
2. Unacceptable fracture risk according to clinician judgement for bone lesions;
3. Brain metastasis, spinal cord compression, superior vena cava obstruction;
4. Bone lesions inside the femoral head/neck;
5. Patients refusing or deemed ineligible for systemic (chemotherapy, hormonal therapy or targeted therapy);
6. History of major radiosensitivity syndrome or contraindications to radiotherapy;
7. Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer);
8. Inability to lie supine for 60 minutes of treatment;
9. Currently pregnant or lactating;
10. Psychiatric or addictive disorders precluding informed consent or adherence to protocol;
11. Geographic inaccessibility for follow-up;
12. Performance status Eastern Cooperative Oncology Group 3 or worse;
13. Inadequate organ function: complete blood count, liver function tests including albumin, bilirubin and International nominalized ratio (INR) (for liver SBRT);
14. Less than 18 years of age.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Systemic therapy plus SBRT to OM

Stereotactic Body Radiotherapy (SBRT) up to 5 OM sites

Interventions

Stereotactic Body Radiotherapy

Five fraction SBRT (or two fraction in case of spine) to any sites of breast cancer oligometastasis using robotic radio surgery or linear accelerator based SBRT

Primary outcome measure

  • Technical feasibility of planning SBRT to multiple sites [ Time Frame: Two weeks from consent ]

Central Contacts and Locations

Central contacts

Elysia Donovan, MD,FRCPC

9053879495donovane@hhsc.ca

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V5C2

Contacts

Elysia K Donovan, MD, FRCPC

905-387-9495donovane@hhsc.ca

Anand Swaminath, MD, FRCPC

905-387-9495swaminath@hhsc.ca

More Information

Sponsor

Juravinski Cancer Center

Last update posted

Jan 29, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Juravinski Cancer Center on 2020-01-29.