Trial Search Results

Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with localized spine metastasis.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: NRG Oncology

Intervention(s):

  • Radiation: External beam radiation therapy
  • Radiation: Radiosurgery/SBRT

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   1. The patient must have localized spine metastasis from the C1 to L5 levels by a
   screening imaging study [bone scan, positron emission tomography (PET), computerized
   tomography (CT), or magnetic resonance imaging (MRI)] (a solitary spine metastasis;
   two separate spine levels; or up to 3 separate sites [e.g., C5, T5-6, and T12] are
   permitted.) Each of the separate sites may have a maximal involvement of 2 contiguous
   vertebral bodies. Patients can have other visceral metastasis, and radioresistant
   tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are
   eligible. See Figure 1 in Section 3.1.1. of the protocol for a depiction of eligible
   metastatic lesions: 1) a solitary spine metastasis; 2) two contiguous spine levels
   involved; or 3) a maximum of 3 separate sites. Each of the separate sites may have a
   maximal involvement of 2 contiguous vertebral bodies. Epidural compression (arrow) is
   eligible when there is a ≥ 3 mm gap between the spinal cord and the edge of the
   epidural lesion (see #10). A paraspinal mass ≤ 5 cm is allowed (see #11).

      - There can be multiple small metastatic lesions shown in other vertebral bodies as
      shown in referenced diagram. The metastatic lesion of each spine should be less
      than 20% of the vertebral body as opposed to the diffuse vertebral involvement.
      These small lesions are often seen in the MRI even when bone scan or PET was
      negative. Most of these lesions are not clinically required to be treated and are
      therefore not included in the target volume of this protocol. Only the painful
      spine (pain score≥ 5) is to be treated .

   2. Zubrod Performance Status 0-2;

   3. Age ≥ 18;

   4. History/physical examination within 2 weeks prior to registration;

   5. Negative serum pregnancy test within 2 weeks prior to registration for women of
   childbearing potential;

   6. Women of childbearing potential and male participants who are sexually active must
   agree to use a medically effective means of birth control;

   7. MRI (contrast is not required but strongly recommended) of the involved spine within 4
   weeks prior to registration to determine the extent of the spine involvement; an MRI
   is required as it is superior to a CT scan in delineating the spinal cord as well as
   identifying an epidural or paraspinal soft tissue component. Note: If an MRI was done
   as a screening imaging study for eligibility (see Section -1), the MRI can be used as
   the required MRI for treatment planning.

   8. Numerical Rating Pain Scale within 1 week prior to registration; the patient must have
   a score on the Scale of ≥ 5 for at least one of the planned sites for spine
   radiosurgery. Documentation of the patient's initial pain score is required. Patients
   taking medication for pain at the time of registration are eligible.

   9. Neurological examination within 1 week prior to registration to rule out rapid
   neurologic decline; see Appendix III for the standardized neurological examination.
   Patients with mild to moderate neurological signs are eligible. These neurological
   signs include radiculopathy, dermatomal sensory change, and muscle strength of
   involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising
   arms and/or arm function).

10. Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap
   between the spinal cord and the edge of the epidural lesion.

11. Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is
   contiguous with spine metastasis are eligible.

12. Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

   1. Histologies of myeloma or lymphoma;

   2. Non-ambulatory patients;

   3. Spine instability due to a compression fracture;

   4. > 50% loss of vertebral body height;

   5. Frank spinal cord compression or displacement or epidural compression within 3 mm of
   the spinal cord;

   6. Patients with rapid neurologic decline;

   7. Bony retropulsion causing neurologic abnormality;

   8. Prior radiation to the index spine;

   9. Patients for whom an MRI of the spine is medically contraindicated;

10. Patients allergic to contrast dye used in MRIs or CT scans or who cannot be
   premedicated for the use of contrast dye.

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting