Clinical trial NCT01898962: Definitive Therapy for Oligometastatic Solid Malignancies
Official title: A Prospective Investigation of Definitive Targeted Therapy for Solid Malignancies With Oligometastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IV or Recurrent Carcinoma or Sarcoma
Keywords: Oligometastases
Metastatic cancer
Stereotactic radiosurgery
Lead sponsor: Rocky Mountain Cancer Centers
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Locoregional disease control
timeFrame: 5 years
measure: Toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers - Boulder
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers - Littleton
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers - Thornton
state: Colorado
Study officials:
affiliation: Rocky Mountain Cancer Centers
name: Dennise Carter, MD
role: PRINCIPAL_INVESTIGATOR
References: