Clinical trial NCT00853528: Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
Official title: Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Cancer
Keywords: spinal cord metastases
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-03-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Maximum tolerated dose - single fraction
timeFrame: 6 weeks
measure: Maximum tolerated dose - hypofraction
timeFrame: 6 weeks
Secondary outcomes:
measure: Assessment of pain
timeFrame: baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment
measure: Spinal cord response
timeFrame: baseline and then at 6 weeks and 6 months after completion of treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Minh-Tam Truong, MD
role: PRINCIPAL_INVESTIGATOR
References: