NCT01345539

Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation

Phase II Study for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Steven Burton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the feasibility of radiosurgery for all metastatic sites in patients presenting with oligometastatic disease, defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems.

Detailed description

Death from metastatic cancer is a common cause of death, accounting for 80-90% of cancer deaths. The classic thought process is that metastatic disease represents the continuum such that known metastatic disease is an inevitable harbinger for subsequent metastatic disease. However, it has been reported that a subset of patients with limited volume metastatic disease may have a better prognosis if given aggressive therapy. This group of patients has become known as "oligometastatic". These patients are potentially curable with stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) (collectively referred to as stereotactic body radiotherapy or SBRT) to the metastatic disease sites in combination with standard curative therapy to the primary site. Patients in this study receive SRS/SBRT to all sites of oligometastatic disease.

Conditions

• Oligometastatic Disease

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery (SRS)	Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
DRUG	Chemotherapy	Chemotherapy choice of agents is at the discretion of the treating medical oncologist.

Timeline

• Start date: 2013-06-07
• Primary completion: 2022-05-03
• Completion: 2022-10-20
• First posted: 2011-05-02
• Last updated: 2023-10-11
• Results posted: 2023-10-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study