Stage IV or Recurrent Carcinoma or Sarcoma
Conditions
Keywords
Oligometastases, Metastatic cancer, Stereotactic radiosurgery
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.
Interventions
PROCEDUREComplete Surgical Removal
RADIATIONStereotactic Radiosurgery
RADIATIONAblative external beam radiation dose
PROCEDURESubtotal 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
RADIATIONRadioembolization
radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques
Sponsors
Rocky Mountain Cancer Centers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 5 years | Overall and disease-specific survival, to be assessed at 1, 3, and 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactRachel Lei, BS
Outcome results
None listed