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Trial record 45 of 46 for:    SIR-Spheres

Definitive Therapy for Oligometastatic Solid Malignancies

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ClinicalTrials.gov Identifier: NCT01898962
Recruitment Status : Unknown
Verified July 2013 by Rocky Mountain Cancer Centers.
Recruitment status was:  Recruiting
First Posted : July 15, 2013
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
Rocky Mountain Cancer Centers

Brief 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.

Condition or disease Intervention/treatment Phase
Stage IV or Recurrent Carcinoma or Sarcoma Procedure: Complete Surgical Removal Radiation: Stereotactic Radiosurgery Radiation: Ablative external beam radiation dose Procedure: Subtotal surgical removal plus ablative radiation dose Radiation: Radioembolization Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Investigation of Definitive Targeted Therapy for Solid Malignancies With Oligometastases
Study Start Date : December 2005
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.
Procedure: Complete Surgical Removal
Radiation: Stereotactic Radiosurgery
Other Name: Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT)

Radiation: Ablative external beam radiation dose
Other Name: 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 Name: 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:
  • Yttrium-90 (Y-90) microspheres
  • Y-90 radioembolization
  • SIR-spheres
  • TheraSphere




Primary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]
    Overall and disease-specific survival, to be assessed at 1, 3, and 5 years.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 5 years ]
    Time to first progression of disease (regardless of location)

  2. Locoregional disease control [ Time Frame: 5 years ]
    Time to first progression within definitively treated areas

  3. Toxicity [ Time Frame: 5 years ]
    Including grade 2+ toxicity attributable to localized study treatment as well as to systemic therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898962


Contacts
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Contact: Rachel Lei, BS 303-418-7607 rachel.lei@usoncology.com

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

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Responsible Party: Rocky Mountain Cancer Centers
ClinicalTrials.gov Identifier: NCT01898962     History of Changes
Other Study ID Numbers: Carter 2005-01
1073869 ( Other Identifier: Western IRB )
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013
Keywords provided by Rocky Mountain Cancer Centers:
Oligometastases
Metastatic cancer
Stereotactic radiosurgery
Additional relevant MeSH terms:
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Sarcoma
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type