Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

Phase 2

Active, not recruiting

Conditions: TNBC - Triple-Negative Breast Cancer
Triple Negative Breast Cancer
NSCLC
NSCLC Stage IV
Non Small Cell Lung Cancer
Non Small Cell Lung Cancer Metastatic
NSCLC Stage IV Without EGFR/ALK Mutation

Interventions: Radiation: Sterotactic Body Radiotherapy/SBRT
Drug: Standard of care

Registration Number: NCT03808662

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary: The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 107

Inclusion Criteria

Age 18 or older
Willing and able to provide informed consent
Metastatic disease detected on imaging and 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 NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)

OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status

OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor

Note:

Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
These patients are selected for the study given the similar survival outcomes when given standard of care therapies
Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies).
Patients who received prior immunotherapy are allowed.
Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.
Patients with the following medical conditions precluding them from participating in other systemic therapy or drug trials are allowed:
active liver disease, including viral or other hepatitis, or cirrhosis
any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months.
a permanent pacemaker
a QTc > 480 ms in the baseline EKG
peripheral neuropathy of grade >/= 2 per NCI CTCAE
history or known autoimmune disease
current chronic systemic steroid therapy or any immunosuppressive therapy
history of primary immunodeficiency or solid organ transplant
known positive human immunodeficiency virus (HIV), chronic or active hepatitis B or C, or active hepatitis A
active infection requiring systemic antibiotic therapy
Patients can have more than 5 metastases but can only have 1-5 oligo-progressive lesions.
Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) documented progression in up to 5 individual lesions

Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria as a guide:

At least a 20% increase in the sum of the longest diameter (LD) of the lesion, taking as reference the smallest sum LD recorded since the last imaging OR
The appearance of one or more new lesions OR
New/malignant FDG uptake in the absence of other indications of progressive disease or an anatomically stable lesion OR
>/= 5mm increase in the diameter sum of the lesion

OR

Using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) as a guide:

>30% increase in 18F-FDG SUV peak, with >0.8 SUV units increase in tumor SUV from the baseline scan in pattern typical of tumor and not of infection/treatment effect OR
Visible increase in the extent of 18F-FDG tumor uptake OR
New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection

OR

Development of a new soft tissue metastatic lesion at least 5mm in size or any new bone metastasis

OR

Progressive enlargement of a known metastasis on 2 consecutive imaging studies at least 2 months apart with a minimum 5mm increase in size

All sites of oligoprogression can be safely treated
Maximum 5 progressing metastases in any single extra-cranial organ system (i.e. lung, liver, bone)

a. If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI
No restriction on the total number of metastases
Note: If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
For patients with brain metastases and oligoprogression elsewhere where stereotactic radiation to the brain is warranted, the brain lesions can be treated prior to randomization. This will not be counted toward the 5 progressive lesions.
Any symptomatic metastatic sites requiring prompt palliative radiation (e.g. cord compression) can also be treated with standard of care radiation prior to randomization. This will not be counted toward the 5 progressive lesions.
1. If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Early Stereotactic Body Radiotherapy/SBRT	Sterotactic Body Radiotherapy/SBRT	SBRT to all oligoprogressive sites
Arm 2:Standard of Care	Standard of care	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Up to 52 weeks after final participant is enrolled	To study if the addition of early SBRT to extra-cranial oligo-progressive metastatic disease could prolong PFS compared to no SBRT. PFS is defined as the time from randomization to disease progression or death.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Trial Locations

Locations (10): Memorial Sloan Kettering Basking Ridge
🇺🇸
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack
🇺🇸
Commack, New York, United States
Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Rockville Centre
🇺🇸
Rockville Centre, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Memorial Sloan Kettering Nassau
🇺🇸
Uniondale, New York, United States
Fred Hutchinson Cancer Research Center (Data Analysis Only)
🇺🇸
Seattle, Washington, United States
Princess Margaret Hospital/Ontario Cancer Institute (Data Analysis Only)
🇨🇦
Toronto, Ontario, Canada
Memorial Sloan Kettering Bergen
🇺🇸
Montvale, New Jersey, United States
Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

Recruitment & Eligibility

Study & Design

Trial Locations

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