Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

Metastatic Cancer Clinical Trial

Official title:

Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853528
• Other study ID #: H-26577
• Secondary ID: W81XWH-07-1-0342
• Status: Completed
• Phase: Phase 1
• First received: February 27, 2009
• Last updated: July 17, 2017
• Start date: January 2009
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.

Description:

OBJECTIVES:

• To implement CyberKnife® technology for improving palliation in patients with spinal metastases.

• To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.

• To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.

OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.

Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2017
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic spinal tumor

• Localized spinal metastasis, defined as one of the following:

• Solitary spinal metastasis

• Two contiguous spinal levels

• No more than 2 adjacent spinal levels involved by a single tumor

• Involvement of = 3 separate sites (e.g., C5, T5, and T12)

• Tumor size = 5 cm

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Life expectancy = 6 months

• Negative pregnancy test

• Fertile patients must use effective contraception

• Must be ambulatory

Exclusion Criteria:

• Not pregnant or nursing

• No spinal instability

• No rapid neurological decline

• No bony retropulsions causing neurological abnormalities

• No total paraplegia for > 48 hours

• No psychological issues that would preclude completion of study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields

• No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance

• No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• questionnaire administration
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment

Procedure:
• diffusion tensor imaging
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
• functional magnetic resonance imaging
prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter

Radiation:
• hypo-fractionated SRS
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
• single-fraction SRS
two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy

Locations

Country	Name	City	State
United States	Boston University Cancer Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose - single fraction	Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery	6 weeks
Primary	Maximum tolerated dose - hypofraction	Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery	6 weeks
Secondary	Assessment of pain	Pain as measured by the Brief Pain Inventory and Roland scale	baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment
Secondary	Spinal cord response	Spinal cord response as measured by functional MRI	baseline and then at 6 weeks and 6 months after completion of treatment