- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898962
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
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 Contact
- Name: Rachel Lei, BS
- Phone Number: 303-418-7607
- Email: rachel.lei@usoncology.com
Study Locations
-
-
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.
|
Other Names:
Other Names:
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:
radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques
Other Names:
|
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
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
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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