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Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)


OBJECTIVES:

Primary

- To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3
months in patients with localized spinal metastasis.

Secondary

- To determine the duration of pain response at the treated site(s) scored as the time of
maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System.

- To determine the functional preservation of improvement as measured by the Brief Pain
Inventory.

- To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires.

- To determine the long-term stability of the treated vertebral bone (e.g., fracture,
sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan,
and plain radiographs.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to
the planned treatment site(s).

- Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body
radiotherapy (SBRT) over 30-90 minutes each.

- Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90
minutes.

Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous
vertebroplasty.

Patients complete pain and quality-of-life questionnaires at baseline and periodically
during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and
then every 6 months for 3 years to assess changes in vertebral bone strength and stability.

After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months,
and then every 6 months for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed cancer as determined by biopsy, prior surgery, or re-biopsy
at the discretion of the treating physician

- Must have localized spinal metastasis, defined as 1 of the following:

- Solitary lesion

- Lesion that spans 2 contiguous levels

- Lesion with a para-spinal component

- Lesion with up to 3 separate single vertebral levels

- Visual analog scoring system pain score ≥ 4 at any of the planned treatment site(s)

- No instability of the spine requiring instrumentation, as judged by a neurosurgeon

- No compression fractures, paraspinal extension, or bony fragments

- No radiation sensitive histology (e.g., lymphoma, multiple myeloma, or plasmacytoma)

- Epidural, spinal nerve, and/or cord compression by MRI allowed

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Platelet count normal

- PT/PTT normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be or have been ambulatory within 1 week prior to study treatment

- No history of significant psychiatric illness

- No severe, active co-morbidity that would preclude vertebroplasty or stereotactic
body radiotherapy, defined as any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

PRIOR CONCURRENT THERAPY:

- More than 1 week since prior chemotherapy

- At least 3 months since prior fractionated radiotherapy to the planned treatment
site(s)

- No planned systemic treatment within 1 week after study treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain

Outcome Description:

Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months

Outcome Time Frame:

3 month

Safety Issue:

No

Principal Investigator

Robert D. Timmerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000634640

NCT ID:

NCT00855803

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • spinal cord metastases
  • unspecified adult solid tumor, protocol specific
  • pain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

University of Texas Southwestern Medical Center - DallasDallas, Texas  75390