A Phase I Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

SUMMARY

You are being asked to take part in this study because you have received treatment to your breast, lung or prostate (the first location of your cancer). Now the cancer has spread to other parts of your body that have not yet been treated. You have received treatment to either your breast, lung, or prostate (the first location of your cancer). The cancer has now spread to other parts of your body that have not been specifically treated. People who are not in a study are usually treated with medications (chemotherapy, hormonal therapy and others) or surgery to help treat their cancer and relieve symptoms. Even if you participate in this study, medications can be given and possibly surgery can be performed or more radtiation can be delivered after the study radiation is completed.

The purpose of this study is to test the safety of giving a few, focused, high doses of radiation (commonly referred to as stereotactic body radiotherapy [SBRT]) to all known sites of cancer within your body.  This study will determine the recommended SBRT dose for each of the locations being treated.  In this study the safety of SBRT to 3-4 cancerous deposits in any organ of the body will be tested.  Additionally, this study will test the safety of giving SBRT to 2 cancerous deposits that are close together,  or 2-3 cancerous deposits that are remaining following surgery to 1-2 other cancerous deposits.

There will be about 84 people taking part in this study.

The dose of radiation to be given to study participants will be based on the location(s) that the cancer has spread to within the body.  The first six study participants with cancer in the same location will receive the starting dose of radiation. If the starting dose does not cause serious side effects, this will be determined to be the safe dose for this location of the body. If there are serious side effects with the starting dose, then a predetermined lower dose will be used to treat additional patients. For different parts of the body where your cancer has spread, you may receive different doses of radiation.

COH Protocol Number : 14297

ClinicalTrials.gov Number : NCT02206334

Principal Investigator : Dandapani, Savita M.D., PhD.

Sponsor : NRG Oncology

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : N/A

Gender : Either

Minimum Performance Status : Zubrod:5

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy : Breast: Allowed

Brain Metastases :

Measurable Disease : Breast: Not Required