Definitive Therapy for Oligometastatic Solid Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Stage IV or Recurrent Carcinoma or Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Definitive locoregional treatment

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.

Group Type EXPERIMENTAL

Complete Surgical Removal

Intervention Type PROCEDURE

Stereotactic Radiosurgery

Intervention Type RADIATION

Ablative external beam radiation dose

Intervention Type RADIATION

Subtotal surgical removal plus ablative radiation dose

Intervention Type PROCEDURE

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

Radioembolization

Intervention Type RADIATION

radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques

Interventions

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Complete Surgical Removal

Intervention Type PROCEDURE

Stereotactic Radiosurgery

Intervention Type RADIATION

Ablative external beam radiation dose

Intervention Type RADIATION

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

Intervention Type PROCEDURE

Radioembolization

radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques

Intervention Type RADIATION

Other Intervention Names

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Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT) External Beam Radiation Therapy (EBRT) with prescribed doses ≥ 45 Gy (biologic equivalent dose) tumors surgically debulked with residual disease or close/positive margins followed by ablative radiation doses Yttrium-90 (Y-90) microspheres Y-90 radioembolization SIR-spheres TheraSphere

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No