Definitive Therapy for Oligometastatic Solid Malignancies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stage IV or Recurrent Carcinoma or Sarcoma

Intervention / Treatment
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* Procedure: Complete Surgical Removal
* Radiation: Stereotactic Radiosurgery
* Radiation: Ablative external beam radiation dose
* Procedure: Subtotal surgical removal plus ablative radiation dose
* Radiation: Radioembolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4 or less distinct sites of active disease. Locoregional disease counts as one site All sites of disease can safely be encompassed by radiation fields to doses ≥ 45 Gy (biologic equivalent dose) and/or removed completely with surgery and/or completely ablated with other appropriate site-specific techniques. sufficient blood cell counts and adequate liver function Exclusion Criteria: Hematologic malignancies Distinct sites of disease > 4 Karnofsky Performance Status < 70 Unexplained weight loss > 10 % HIV, chronic viral hepatitis, or any chronically active infection Life expectancy < 6 months for any reason

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Definitive locoregional treatment<br>All sites of active disease should be treated definitively (with one of the interventions listed below). Definitive treatment does not have to be the same for all sites of disease. | Procedure: Complete Surgical Removal<br> <br> Radiation: Stereotactic Radiosurgery<br> <br> * Other names: Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT);Radiation: Ablative external beam radiation dose<br> <br> * Other names: External Beam Radiation Therapy (EBRT) with prescribed doses ≥ 45 Gy (biologic equivalent dose);Procedure: Subtotal surgical removal plus ablative radiation dose<br>* 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<br>* Other names: tumors surgically debulked with residual disease or close/positive margins followed by ablative radiation doses;Radiation: Radioembolization<br>* radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques<br>* Other names: TheraSphere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall and disease-specific survival, to be assessed at 1, 3, and 5 years. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Time to first progression of disease (regardless of location) | 5 years | 
| Locoregional disease control | Time to first progression within definitively treated areas | 5 years | 
| Toxicity | Including grade 2+ toxicity attributable to localized study treatment as well as to systemic therapy | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oligometastases, Metastatic cancer, Stereotactic radiosurgery