Definitive Therapy for Oligometastatic Solid Malignancies

Rocky Mountain Cancer Centers

Status and phase: Unknown; Phase 2

Conditions: Stage IV or Recurrent Carcinoma or Sarcoma

Treatments: Radiation: Radioembolization; Radiation: Stereotactic Radiosurgery; Procedure: Complete Surgical Removal; Procedure: Subtotal surgical removal plus ablative radiation dose; Radiation: Ablative external beam radiation dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01898962

Carter 2005-01

1073869 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Definitive locoregional treatment

Experimental group

Description:

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.

Treatment:

Radiation: Ablative external beam radiation dose

Procedure: Subtotal surgical removal plus ablative radiation dose

Radiation: Stereotactic Radiosurgery

Radiation: Radioembolization

Procedure: Complete Surgical Removal