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. (phase II completed as of 8-30-11)
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborator: NRG Oncology
Stanford Investigator(s):
Intervention(s):
- Radiation: external beam radiation therapy
- Radiation: image-guided radiation therapy
- Radiation: radiosurgery
- Radiation: stereotactic body radiation therapy
Phase:
Phase 2/Phase 3
Eligibility
DISEASE CHARACTERISTICS:
- Diagnosis of localized spine metastasis at the C1 to L5 levels by a screening imaging
study (bone scan, PET, CT, or MRI), meeting any of the following criteria:
- Solitary spine metastasis
- Two contiguous spine levels involved
- No more than 3 separate sites (e.g., C5, T5-6, and T12) involved
- No more than 2 contiguous vertebral bodies involved at each separate site
- Other visceral metastasis, and radioresistant tumors (including soft tissue
sarcomas, melanomas, and renal cell carcinomas) are eligible
- No myeloma or lymphoma
- Epidural compression allowed provided there is ≥ 3 mm gap between the spinal cord and
edge of epidural lesion
- Paraspinal mass allowed provided it is ≤ 5 cm in the greatest dimension and contiguous
with spine metastasis
- Has undergone MRI of the involved spine within the past 4 weeks to determine the
extent of spine involvement
- No spine metastasis that is not planned to be treated per protocol
- No rapid neurologic decline
- Mild to moderate neurological signs, including 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), allowed
- No spine instability due to compression fracture, frank spinal cord compression or
displacement, or epidural compression within 3 mm of the spinal cord
- No more than 50% loss of vertebral body height
- No bony retropulsion causing neurologic abnormality
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be ambulatory
- No medical contraindications to an MRI of the spine
- No allergy to contrast dye used in MRI or CT scans
- The patient must have a score on the Numerical Rating Pain Scale of ≥ 5 within 1 week
prior to registration 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
PRIOR CONCURRENT THERAPY:
- Concurrent pain medication allowed
- No prior radiotherapy to the index spine
- No chemotherapy for ≥ 24 hours before, during, and for ≥ 24 hours after completion of
radiosurgery
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