NCT01898962

Definitive Therapy for Oligometastatic Solid Malignancies

A Prospective Investigation of Definitive Targeted Therapy for Solid Malignancies With Oligometastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Rocky Mountain Cancer Centers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with metastatic cancer are usually treated with systemic therapy (treating the entire body) with the assumption that any localized treatment of clinically apparent metastases would not impact survival. In the setting of increasingly effective systemic therapy and limited metastatic disease, aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival.

Detailed description

Up to recently it has been assumed that in the setting of metastatic solid tumors, locoregional control of clinically apparent metastases does not substantially impact survival due to undetectable micrometastic (clinically not visualized) disease that ultimately lead to treatment failure/progression. However, as more advanced systemic therapy continue to improve control of micrometastatic disease, failures at the original sites of disease remain common. Furthermore, some studies have shown locoregional treatment of limited clinical metastases to actually improve survival. Therefore, the investigators hypothesize that aggressive treatment to clinically active sites of disease (alone or in addition to systemic therapy) may improve survival or alter the course of the disease in some patients with limited metastatic disease.

Conditions

• Stage IV or Recurrent Carcinoma or Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Complete Surgical Removal
RADIATION	Stereotactic Radiosurgery
RADIATION	Ablative external beam radiation dose
PROCEDURE	Subtotal surgical removal plus ablative radiation dose	Residual tumor or close/positive margins should be followed by ablative radiation doses (by either stereotactic radiosurgery or convential EBRT) to constitute definitive locoregional treatment
RADIATION	Radioembolization	radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques

Timeline

• Start date: 2005-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2013-07-15
• Last updated: 2013-07-15

Locations

4 sites across 1 country: United States