Recruiting
Phase 2

Observational Study

Sponsor:

Rocky Mountain Cancer Centers

Code:

NCT01898962

Conditions

Stage IV or Recurrent Carcinoma or Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Complete Surgical Removal

Stereotactic Radiosurgery

Ablative external beam radiation dose

Subtotal surgical removal plus ablative radiation dose

Radioembolization

Study Details

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.

Conditions

Stage IV or Recurrent Carcinoma or Sarcoma

Study ID

NCT01898962

Start date

Dec, 2005

Status verified date

Jul, 2013

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

110 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Complete Surgical Removal

Stereotactic Radiosurgery

Ablative external beam radiation dose

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

Radioembolization

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

Primary outcome measure

  • Survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Rachel Lei, BS

303-418-7607rachel.lei@usoncology.com

Locations

Rocky Mountain Cancer Centers - Aurora

Recruiting

Aurora, Colorado, United States, 80012

Principal Investigator:

Dennis Carter, MD

Rocky Mountain Cancer Centers - Boulder

Recruiting

Boulder, Colorado, United States, 80303

Rocky Mountain Cancer Centers - Littleton

Recruiting

Littleton, Colorado, United States, 80120

Rocky Mountain Cancer Centers - Thornton

Recruiting

Thornton, Colorado, United States, 80260

More Information

Sponsor

Rocky Mountain Cancer Centers

Last update posted

Jul 15, 2013

Last verified

Jul, 2013

Keywords

  • Oligometastases
  • Metastatic cancer
  • Stereotactic radiosurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rocky Mountain Cancer Centers on 2013-07-15.