Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:January 16, 2019
End Date:January 2022
Contact:T. Jonathan Yang, MD, PhD
Email:yangt@mskcc.org
Phone:212-639-8157

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A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer.

This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered
to all sites of disease in participants with 1-5 metastases will increase the length of time
before participants' disease gets worse.


Inclusion Criteria:

- Histologically confirmed triple negative breast cancer (TNBC) (ER <1%, PR <1%,
her-2-neu 0-1+ by IHC or FISH-negative or as determined by MD discretion), or
non-small cell lung cancer (NSCLC) without detectable targetable molecular alterations
in EGFR, ALK or ROS1.

- Pathologically confirmed metastatic disease.

- Patient can either have newly diagnosed metastatic disease, or have non-progressive
disease on systemic therapy

- Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5
or fewer discrete disease sites that are technically amendable to SBRT (with the
exception that if the primary disease is not amendable to SBRT it is allowed to be
treated with conventionally fractionated or hypfractionated radiotherapy).

- Two lesions in such close proximity to one another that treatment with one
isocenter is more accurate and safer in the liver, lungs, or other similar
anatomic locations should be viewed as one site of metastatic disease treatment

- Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal
extension) can represent one site of disease in the spine; non-contiguous lesions
in vertebral bodies separated by one vertebral body free of disease should be
viewed as 2 sites of treatment

- For de novo stage IV patients (patients with metastatic disease at first
presentation), primary disease must be treatable with local therapy. If the primary
tumor or other locoregional disease has not been definitively treated and is not
amendable to SBRT, it must be treated with conventionally fractionated or
hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10

- If primary disease was previously treated with local therapy in the form of surgery or
radiation, any new local/regional disease recurrence should be technically treatable
with SBRT or hypofractionated radiation.

- Patients may receive palliative radiotherapy for symptomatic metastases or primary
disease prior to enrollment provided that there is at least one other non-irradiated
lesion amenable to SBRT at the time of enrollment.

- Patients with brain metastases are eligible if these lesions have been treated prior
to enrollment.

- ECOG Performance status 0 - 2.

- Age >/= 18 years.

- Able to provide informed consent.

- Female subjects must either be of non-reproductive potential (i.e. post-menopausal by
history: >/= 60 years old and no menses for 1> year without an alternative medical
cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history
of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks
prior to starting treatment.

- Adequate baseline organ function to allow SBRT to all relevant targets, as determined
by the treating radiation oncologist based on lesion location, lesion size, and
proximity to relevant organs at risk.

Exclusion Criteria:

- Serious medical co-morbidities precluding radiotherapy, determined at the discretion
of the treating investigator.

- Pregnant or lactating women.

- Other active malignancy within the last year, even if without evidence of disease.

- Clinical or radiological evidence of spinal cord compression

- Malignant pleural effusion or ascites.

- Patients whose entry to the trial will cause unacceptable clinical delays in their
planned management.
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Harrison, New York
Phone: 212-639-8157
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
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Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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480 Red Hill Road
Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-8157
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1000 North Village Avenue
Rockville Centre, New York 11570
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Uniondale, New York 11553
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