Definitive Therapy for Oligometastatic Solid Malignancies

NCT01898962 | Unknown Phase 2

• 2 other identifiers: Carter 2005-011073869
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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.

Conditions

Stage IV or Recurrent Carcinoma or Sarcoma

Keywords

Oligometastases; Metastatic cancer; Stereotactic radiosurgery

Outcome Measures

Primary Outcomes (1)

• Survival

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

  5 years

Secondary Outcomes (3)

• Progression free survival (PFS)

  5 years

• Locoregional disease control

  5 years

• Toxicity

  5 years

Study Arms (1)

Definitive locoregional treatment

EXPERIMENTAL

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; Radiation: Ablative external beam radiation dose; Procedure: Subtotal surgical removal plus ablative radiation dose; Radiation: Radioembolization

Interventions

Complete Surgical Removal PROCEDURE

Definitive locoregional treatment

Stereotactic Radiosurgery RADIATION

Also known as: Stereotactic radiosurgery (SRS) for extracranial metastases are also known as streotactic body radiotherapy (SBRT)

Definitive locoregional treatment

Ablative external beam radiation dose RADIATION

Also known as: External Beam Radiation Therapy (EBRT) with prescribed doses ≥ 45 Gy (biologic equivalent dose)

Definitive locoregional treatment

Subtotal surgical removal plus ablative radiation dose PROCEDURE

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

Also known as: tumors surgically debulked with residual disease or close/positive margins followed by ablative radiation doses

Definitive locoregional treatment

Radioembolization RADIATION

radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques

Also known as: Yttrium-90 (Y-90) microspheres, Y-90 radioembolization, SIR-spheres, TheraSphere

Definitive locoregional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rocky Mountain Cancer Centers: lead

Study Sites (4)

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

RECRUITING

Rocky Mountain Cancer Centers - Boulder

Boulder, Colorado, 80303, United States

RECRUITING

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, 80120, United States

RECRUITING

Rocky Mountain Cancer Centers - Thornton

Thornton, Colorado, 80260, United States

RECRUITING

MeSH Terms

Conditions

Recurrence; Sarcoma; Neoplasm Metastasis

Interventions

Radiosurgery; Spermine Synthase; Yttrium-90; Microspheres

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes; Equipment and Supplies

Study Officials

• Dennise Carter, MD

  Rocky Mountain Cancer Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Lei, BS

CONTACT

303-418-7607; rachel.lei@usoncology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 15, 2013
• Study Start: December 1, 2005
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

US (4)