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

Conditions

• Metastatic Breast Cancer
• Metastatic Non-Small Cell Lung Carcinoma
• Non Small Cell Lung Cancer
• Triple Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stereotactic Body Radiotherapy/SBRT — RADIATION
  Radiation to each metastatic site should be delivered to a minimum dose of 30 Gy in 5 fractions (BED of 48 Gy10). The exact dose of radiotherapy will be determined by the treating radiation oncologist. Preferred regimens for lung metastases include 50 Gy in five fractions, 48 Gy in four fractions, or 54 Gy in three fractions, although lower doses may be employed to respect dose limits to critical structures such as the esophagus. Recommended SBRT dosing for other sites includes 27 to 30 Gy in three fractions or 24 Gy in one fraction for bone metastases.
• Systemic Therapy/Standard of Care — DRUG
  Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. For patients randomized to receive SBRT, systemic therapy can be continued during SBRT at the discretion and concensus of treating physicians (medical oncologist and radiation oncologist). If the treating physicians recommend discontinuing systemic therapy during SBRT, general guidelines for stopping and reinitiating systemic regimen are as follows: Hormonal therapies and immunotherapy can be continued during SBRT. Consideration can be given to holding cytotoxic chemotherapy beginning 3 to 7 days prior to the initiation of SBRT until 3 to 7 days after the completion of SBRT. Similarly, consideration can be given to holding biologic agents during SBRT and for 0 to 3 days before and after.

Study Details

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.

Key Dates

Start date

Jan 16, 2019

Status verified

Feb 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

145 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standare of Care
  Patients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist.
• Experimental: Stereotactic Body Radiotherapy (SBRT) + Standard of Care
  Patients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to 2 years ]

Central Contacts

• Amy Xu, MD, PhD
  646-888-6863
  [email protected]
• Wanqing Zhi, MD, PhD
  631-623-4246
  [email protected]

Locations (12)

Find similar trials in San Carlos, CA

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