Definitive Therapy for Oligometastatic Solid Malignancies

• Sponsor: Rocky Mountain Cancer Centers (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01898962
• Collaborator: (none)
• Enrollment: 110
• Locations: 4
• Arm: 1
• Duration (Months): 156
• Patients Per Site: 27.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV or Recurrent Carcinoma or Sarcoma	Procedure: Complete Surgical Removal; Radiation: Stereotactic Radiosurgery; Radiation: Ablative external beam radiation dose; Procedure: Subtotal surgical removal plus ablative radiation dose; Radiation: Radioembolization	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Investigation of Definitive Targeted Therapy for Solid Malignancies With Oligometastases
• Study Start Date: Dec 1, 2005
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

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.

Procedure: Complete Surgical Removal; Radiation: Stereotactic Radiosurgery; Other Names: Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT) ; Radiation: Ablative external beam radiation dose; Other Names: External Beam Radiation Therapy (EBRT) with prescribed doses ≥ 45 Gy (biologic equivalent dose) ; Procedure: 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; Other Names: tumors surgically debulked with residual disease or close/positive margins followed by ablative radiation doses ; Radiation: Radioembolization; radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques; Other Names: Yttrium-90 (Y-90) microspheres Y-90 radioembolization SIR-spheres TheraSphere

Outcome Measures

Primary Outcome Measures

1. Survival [5 years]

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

Secondary Outcome Measures

1. Progression free survival (PFS) [5 years]

   Time to first progression of disease (regardless of location)

2. Locoregional disease control [5 years]

   Time to first progression within definitively treated areas

3. Toxicity [5 years]

   Including grade 2+ toxicity attributable to localized study treatment as well as to systemic therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado	United States	80012
2	Rocky Mountain Cancer Centers - Boulder	Boulder	Colorado	United States	80303
3	Rocky Mountain Cancer Centers - Littleton	Littleton	Colorado	United States	80120
4	Rocky Mountain Cancer Centers - Thornton	Thornton	Colorado	United States	80260

Sponsors and Collaborators

• Rocky Mountain Cancer Centers

Investigators

• Principal Investigator: Dennise Carter, MD, Rocky Mountain Cancer Centers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rocky Mountain Cancer Centers
• ClinicalTrials.gov Identifier: NCT01898962
• Other Study ID Numbers: Carter 2005-01; 1073869
• First Posted: Jul 15, 2013
• Last Update Posted: Jul 15, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Rocky Mountain Cancer Centers: Oligometastases; Metastatic cancer; Stereotactic radiosurgery
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of Jul 15, 2013