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Stereotactic Body Radiotherapy for Patients With Breast Cancer Oligometastasis (STOMP)

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ClinicalTrials.gov Identifier: NCT03295916
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Toronto Sunnybrook Regional Cancer Centre
Information provided by (Responsible Party):
Elysia Donovan, Juravinski Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Stereotactic Body Radiotherapy Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiotherapy (SBRT) for the Treatment of OligoMetastasis in Breast Cancer Patients (STOMP): A Prospective Feasibility Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Systemic therapy plus SBRT to OM
Stereotactic Body Radiotherapy (SBRT) up to 5 OM sites
Radiation: 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 Measures :
  1. Technical feasibility of planning SBRT to multiple sites [ Time Frame: Two weeks from consent ]
    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.


Secondary Outcome Measures :
  1. Toxicity: Incidence of treatment-emergent adverse events [safety and tolerability] as assessed by CTCAE 4.0 [ Time Frame: One week, 3,6, 12 months from SBRT treatment ]
    Incidence of treatment-emergent adverse events [safety and tolerability] as assessed by CTCAE 4.0

  2. Feasibility of patient accrual: Successful accrual of 30 patients to study [ Time Frame: At 12 months from study initiation ]
    Successful accrual of 30 patients to study

  3. Local Control: CT scan or MRI as assessed by RECIST criteria 1.1 [ Time Frame: 3, 6, 12 months from SBRT treatment ]
    CT scan or MRI as assessed by RECIST criteria 1.1

  4. Progression Free Survival (PFS) [ Time Frame: 3, 6, 12 months from SBRT treatment ]
    CT scan or MRI as assessed by RECIST criteria 1.1

  5. Overall Survival (OS) [ Time Frame: 3, 6 12 months from SBRT treatment ]
    OS in months censored at last follow up

  6. Quality of Life defined by EORTC Quality of Life Questionnaire core-30 [ Time Frame: One week, 3, 6, 12 months from SBRT treatment ]
    Patient-reported, defined by EORTC Quality of Life Questionnaire core-30



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

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.

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): NCT03295916


Contacts
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Contact: Elysia Donovan, MD,FRCPC 9053879495 donovane@hhsc.ca

Locations
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Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V5C2
Contact: Elysia K Donovan, MD, FRCPC    905-387-9495    donovane@hhsc.ca   
Contact: Anand Swaminath, MD, FRCPC    905-387-9495    swaminath@hhsc.ca   
Sponsors and Collaborators
Juravinski Cancer Center
Toronto Sunnybrook Regional Cancer Centre
Investigators
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Principal Investigator: Anand Swaminath, MD,FRCPC McMaster University
Publications:
9. Jain SK, Dorn PL, Chmura SJ, Weischelbaum RR. Incidence and implications of oligometastatic breast cancer. J Clin Oncol. 2012;30 Suppl:e11512.
Lutz S, Balboni T, Jones J et al. Palliative radiation therapy for bone metastases: Update of an ASTRO Evidence-Based Guideline. Practical Radiation Oncology. Published online August 5 2016. www.practicalradonc.org/article/S1879-8500(16)30122-9/abstract
Kucharczyk MJ, Swaminath A. Ablative Therapy for Metastatic Breast Cancer - A Systematic Review. Radiotherapy & Oncology. 2015;116(S1):S27-28.
Common Terminology Criteria for Adverse Events (CTCAE) Version 4.3. US Department of Health, National Institutes of Health and National Cancer Institude. 2010. Published online: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
Response assessment in solid tumors (RECIST):Version 1.1 and Supporting Papers. European Journal of Cancer. 2009. 45 (2): 225-310.
European Organization for Research and Treatment of Cancer (EORTC) quality of life group. EORTC core Quality of Life Questionnare-30 (Version 3). 2001. Published online: http://groups.eortc.be/qol/sites/default/files/img/slider/specimen_qlq-c30_english.pdf

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Responsible Party: Elysia Donovan, Local Principal Investigator, Juravinski Cancer Center
ClinicalTrials.gov Identifier: NCT03295916    
Other Study ID Numbers: 3764
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified patient data may be shared with other participating centres (Odette Sunnybrook Cancer Centre)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases