Definitive Therapy for Oligometastatic Solid Malignancies

July 10, 2013 updated by: Rocky Mountain Cancer Centers

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers - Aurora
        • Principal Investigator:
          • Dennis Carter, MD
        • Sub-Investigator:
          • William Daniel, MD
      • Boulder, Colorado, United States, 80303
        • Recruiting
        • Rocky Mountain Cancer Centers - Boulder
        • Sub-Investigator:
          • Andrew Antell, MD
        • Sub-Investigator:
          • Meera Patel, MD
        • Sub-Investigator:
          • Ralph Wright, MD
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Rocky Mountain Cancer Centers - Littleton
        • Sub-Investigator:
          • Charles Leonard, MD
        • Sub-Investigator:
          • Kathryn Howell, MD
      • Thornton, Colorado, United States, 80260
        • Recruiting
        • Rocky Mountain Cancer Centers - Thornton
        • Sub-Investigator:
          • Robert LaPorte, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: Stereotactic Radiosurgery
Other Names:
  • Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT)
Procedure: Complete Surgical Removal
Radiation: Ablative external beam radiation dose
Other Names:
  • External Beam Radiation Therapy (EBRT) with prescribed doses ≥ 45 Gy (biologic equivalent 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
Other Names:
  • tumors surgically debulked with residual disease or close/positive margins followed by ablative radiation doses
Radiation: Radioembolization
radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques
Other Names:
  • TheraSphere
  • Yttrium-90 (Y-90) microspheres
  • Y-90 radioembolization
  • SIR-spheres

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rocky Mountain Cancer Centers

Investigators

  • Principal Investigator: Dennise Carter, MD, Rocky Mountain Cancer Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carter 2005-01
  • 1073869 (Other Identifier: Western IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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