Definitive Therapy for Oligometastatic Solid Malignancies

Phase 2

• Conditions: Stage IV or Recurrent Carcinoma or Sarcoma
• Interventions: Procedure: Complete Surgical Removal; Radiation: Stereotactic Radiosurgery; Radiation: Ablative external beam radiation dose; Procedure: Subtotal surgical removal plus ablative radiation dose; Radiation: Radioembolization

• Registration Number: NCT01898962
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-12
• Status Verified: 2013-07
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-10
• Last Update Submitted: 2013-07-10
• Study First Posted: 2013-07-15
• Last Update Posted: 2013-07-15
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definitive locoregional treatment	Complete Surgical Removal	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.
Definitive locoregional treatment	Stereotactic Radiosurgery	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.
Definitive locoregional treatment	Ablative external beam radiation dose	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.
Definitive locoregional treatment	Subtotal surgical removal plus ablative radiation dose	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.
Definitive locoregional treatment	Radioembolization	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.

Primary Outcome Measures

Name	Time	Method
Survival	5 years	Overall and disease-specific survival, to be assessed at 1, 3, and 5 years.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	5 years	Time to first progression of disease (regardless of location)
Locoregional disease control	5 years	Time to first progression within definitively treated areas
Toxicity	5 years	Including grade 2+ toxicity attributable to localized study treatment as well as to systemic therapy

Trial Locations

Locations (4)

Rocky Mountain Cancer Centers - Boulder; 🇺🇸 Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Littleton; 🇺🇸 Littleton, Colorado, United States

Rocky Mountain Cancer Centers - Aurora; 🇺🇸 Aurora, Colorado, United States

Rocky Mountain Cancer Centers - Thornton; 🇺🇸 Thornton, Colorado, United States