Stereotactic Radiosurgery (SRS) for Spine Metastases

Spinal Metastases Clinical Trial

— SRS  

Official title:

Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00593320
• Other study ID #: 07-0658
• Status: Terminated
• Phase: N/A
• First received: January 2, 2008
• Last updated: February 18, 2015
• Start date: September 2007
• Est. completion date: March 2010

Study information

• Verified date: February 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).

Description:

This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent.

• Age greater than or equal to 18 years old.

• Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).

• Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.

• Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).

• Maximum tumor size less than or equal to 5 cm.

• Zubrod performance status of less than or equal to 3.

• Life expectancy of greater than or equal to 3 months.

• Women/Men of childbearing potential must use effective contraception.

Exclusion Criteria:

• No prior radiation delivered to the involved area

• No evidence of spinal instability requiring urgent surgical intervention.

• No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.

• No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.

• No pregnant or lactating women.

• No active systemic infection.

• No evidence of myelopathy or cauda equina syndrome on clinical evaluation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Radiation:
• Stereotactic Radiosurgery

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Control Rate as Measured by the The Brief Pain Inventory	The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.	6 months after completion of treatment	Yes
Primary	Musculoskeletal Function as Measured by the Oswestry Disability Index	The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.	6 months after completion of treatment	No
Primary	Quality of Life as Measured by the FACT-CNS Questionnaire	The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns.; Participants can choose 0 (Not At All) up to 4 (Very Much) for each question.	6 months after completion of treatment	No
Secondary	Local Control Rate	Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.	6 months after end of treatment	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine