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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Radiation Therapy Oncology Group
Sponsor:
Collaborators:
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00922974
First received: June 17, 2009
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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)


Condition Intervention Phase
Metastatic Cancer
Pain
Radiation: external beam radiation therapy
Radiation: image-guided radiation therapy
Radiation: radiosurgery
Radiation: stereotactic body radiation therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Successful delivery of image-guided radiosurgery or stereotactic body radiotherapy in the Radiation Therapy Oncology Group (RTOG) cooperative group setting (Phase II) [ Time Frame: End of protocol treatment ] [ Designated as safety issue: No ]
  • Complete or partial pain response at the treated index site(s) at 3 months after study entry, as measured by the Numerical Rating Pain Scale (NRPS) (Phase III) [ Time Frame: Pre-treatment to 3 months from study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rapidity of pain response, defined as time from study entry to complete or partial pain relief (Phase III) [ Time Frame: Pre-treatment up to 24 months from study entry ] [ Designated as safety issue: No ]
  • Duration of pain response, defined as time from complete or partial pain relief to pain worsening (≥ 3 points on the NRPS) (Phase III) [ Time Frame: Pre-treatment to 24 months from study entry ] [ Designated as safety issue: No ]
  • Adverse events, as measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 criteria (Phase III) [ Time Frame: Up to 24 months from study entry ] [ Designated as safety issue: Yes ]
  • Long-term effects (24 months) of treatment on the vertebral bone (e.g., compression fracture) and spinal cord (Phase III) [ Time Frame: Pre-treatment to 24 months from study entry ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: November 2009
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (phase III)
Patients undergo 1 high-dose image-guided radiosurgery or SBRT treatment over 60 minutes.
Radiation: image-guided radiation therapy
Patients undergo 1 high-dose image-guided radiosurgery treatment.
Radiation: radiosurgery
Patients undergo 1 high-dose image-guided radiosurgery treatment.
Radiation: stereotactic body radiation therapy
Patients undergo 1 high-dose image-guided SBRT treatment.
Active Comparator: Arm II (phase III)
Patients undergo 1 standard-dose external beam radiotherapy treatment over 5 minutes.
Radiation: external beam radiation therapy
Patients undergo 1 standard-dose external beam radiotherapy treatment.

Detailed Description:

OBJECTIVES:

Primary

  • 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)

Secondary

  • 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 other).

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922974

  Show 38 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
NRG Oncology Foundation, Inc.
Investigators
Principal Investigator: Samuel Ryu, MD Josephine Ford Cancer Center at Henry Ford Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00922974     History of Changes
Other Study ID Numbers: RTOG-0631, CDR0000646803, NCI-2009-01687
Study First Received: June 17, 2009
Last Updated: July 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
spinal bone metastases
pain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014