Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04424732

SBRT for Breast Cancer Oligometastases

Led by King Hussein Cancer Center · Updated on 2020-06-11

50

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.

CONDITIONS

Official Title

SBRT for Breast Cancer Oligometastases

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women older than 18 years with pathologically confirmed breast cancer presenting with 1-3 bone metastases
  • Metastases confirmed by pathology if possible, or by two different imaging methods (CT or MRI plus bone scan or PET)
  • Ability to receive recommended systemic and local treatments
  • Primary breast tumor must be controlled at time of SBRT
  • Each metastasis must be 5 cm or smaller in any dimension
  • Metastases must be more than 5 cm apart from each other (edge to edge)
Not Eligible

You will not qualify if you...

  • Breast cancer metastases not limited to bone
  • Prior radiotherapy to the same sites planned for SBRT
  • Pathologic fractures of bones involved
  • Contraindications to radiotherapy such as pregnancy or connective tissue diseases
  • Patients with impaired cognitive function

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

King Hussein Cancer Center

Amman, Jordan, 11941

Actively Recruiting

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Research Team

A

Abdulmajeed H Dayyat, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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SBRT for Breast Cancer Oligometastases | DecenTrialz