Stereotactic Body Radiotherapy for Patients With Breast Cancer Oligometastasis

NCT03295916 | Unknown Early Phase 1 DMC

• 1 other identifier: 3764
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Technical feasibility of planning SBRT to multiple sites

  Successful planning and delivery of SBRT to multiple sites, defined by covering 95% of target volume with 95% of prescribed dose, while keeping within established normal tissue constraints for 2, 3, 5 fraction SBRT.

  Two weeks from consent

Secondary Outcomes (6)

• Toxicity: Incidence of treatment-emergent adverse events [safety and tolerability] as assessed by CTCAE 4.0

  One week, 3,6, 12 months from SBRT treatment

• Feasibility of patient accrual: Successful accrual of 30 patients to study

  At 12 months from study initiation

• Local Control: CT scan or MRI as assessed by RECIST criteria 1.1

  3, 6, 12 months from SBRT treatment

• Progression Free Survival (PFS)

  3, 6, 12 months from SBRT treatment

• Overall Survival (OS)

  3, 6 12 months from SBRT treatment

Study Arms (1)

Systemic therapy plus SBRT to OM

EXPERIMENTAL

Stereotactic Body Radiotherapy (SBRT) up to 5 OM sites

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body Radiotherapy RADIATION

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

Systemic therapy plus SBRT to OM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• No more than 12 months may have passed since diagnosis of OM disease;
• Total burden of disease limited to 5 metastatic sites or less, and the size of each metastatic lesion must be less than 5 centimeters;
• All lesions amenable to SBRT (lesions may overlap if treatable at discretion of Radiation Oncologist).

You may not qualify if:

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

Sponsors & Collaborators

• Juravinski Cancer Center: lead
• Toronto Sunnybrook Regional Cancer Centre: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2, Canada

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anand Swaminath, MD,FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elysia Donovan, MD,FRCPC

CONTACT

9053879495; donovane@hhsc.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Local Principal Investigator

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 28, 2017
• Study Start: January 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

CA (1)