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Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

Phase 2/Phase 3
18 Years
Open (Enrolling)
Metastatic Cancer, Pain

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Trial Information

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis



- Determine the feasibility of successfully delivering image-guided radiosurgery or
stereotactic body radiotherapy (SBRT) in patients with spine metastases in a
cooperative group setting. (Phase II) (completed as of 8-30-11)

- Determine whether image-guided radiosurgery or SBRT (single dose of 16 Gy) improves
pain control (as measured by the 11-point Numerical Rating Pain Scale [NRPS]) compared
to conventional external beam radiotherapy (single dose of 8 Gy). (Phase III)


- Determine whether image-guided radiosurgery or SBRT improves the rapidity of pain
response and increases the duration of pain response at the treated site(s) compared to
conventional external beam radiotherapy, as measured by the NRPS. (Phase III)

- Compare adverse events associated with these treatment regimens, as measured by NCI
CTCAE v3.0 criteria. (Phase III)

- Evaluate the long-term effects (24 months) of image-guided radiosurgery or SBRT on the
vertebral bone (e.g., compression fracture) and the spinal cord, as measured by MRI.
(Phase III)

OUTLINE: This is a multicenter, phase II study (completed as of 8-30-11) followed by a
randomized phase III study. Patients enrolled in the phase III portion are stratified
according to the number of spine metastases to be treated (1 vs 2-3) and the type of tumor
(radioresistant [including soft tissue sarcomas, melanomas, and renal cell carcinomas] vs

- Phase II: Patients undergo 1 high-dose image-guided radiosurgery or stereotactic body
radiotherapy (SBRT) treatment over 60 minutes. (completed as of 8-30-11)

- Phase III: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo 1 high-dose image-guided radiosurgery or SBRT treatment
over 60 minutes.

- Arm II: Patients undergo 1 standard-dose external beam radiotherapy treatment over
5 minutes.

Patients undergo MRI of the treated spine at baseline and at 3, 6, 12, and 24 months*.
Patients enrolled in the phase III portion also complete the Numerical Rating Pain Scale at
baseline, at 1, 2, and 3 weeks after randomization, and at 1, 3, 6, 12, and 24 months.

NOTE: *Patients enrolled in the phase II portion undergo MRI at baseline and at 3 months.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Successful delivery of image-guided radiosurgery or stereotactic body radiotherapy in the Radiation Therapy Oncology Group (RTOG) cooperative group setting (Phase II)

Outcome Time Frame:

End of protocol treatment

Safety Issue:


Principal Investigator

Samuel Ryu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Josephine Ford Cancer Center at Henry Ford Hospital


United States: Federal Government

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Pain
  • spinal bone metastases
  • pain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



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