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Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis

Phase 2
18 Years
Open (Enrolling)
Primary Tumor, Metastatic Cancer

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Trial Information

Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis

Randomization means that you are put into a group by chance. It is like flipping a coin.
Neither you nor the research doctor will choose what group you will be in.

You will have a 2 to 1 chance of being placed in the SBRT to standard radiation group. Since
SBRT is the newer treatment being tested, we would like to include more patients in this

Treatment Procedures:

SBRT: You may receive one, three or five SBRT treatments depending on the extent of your
cancer. During each treatment you will be assessed by a nurse and a physician for a physical
and neurological assessment. The treatment itself would last approximately I hour where you
will be lying on a treatment table. Prior to each treatment you will have a physical and
neurological assessment by a physician. Standard Radiation: You will receive ten consecutive
working days of standard radiation. While each treatment lasts five to ten minutes, the
entire visit may last up to thirty minutes. During the treatment you will be lying on a
treatment table. Once per week you will have a physical and neurological assessment by your
treating physician After the final treatment of the study therapy: We would like to keep
track of your medical condition for at least 12 months after you receive treatment. We would
like to do this by having you come in to the clinic at months 1, 3, 6, 12 and 24 months
after treatment*. At these visits we will be looking for the same information as during the
screening time frame. This includes:

- A history and physical from you

- A Performance Status of how you are able to carry on with your usual activities.

- A Pain scale questionnaire called the Numerical Rating Pain Scale(NRPS) that asks to
explain your pain symptoms on a 0-10 scale

- 3 Quality Of Life (QOL) Assessments described below:

- Functional Assessment of Cancer Therapy-General (FACT-G)

- The Brief Pain Inventory (BPI)

- The EuroQOL (EQ-5D)

- An assessment of your tumor by MRI (Magnetic Resonance Imaging)

Inclusion Criteria:

- Histologically confirmed primary tumor or metastatic cancer with radiological
diagnosis of spine metastasis

- The patient must have localized spine metastasis from the C1 to L5 levels by a
screening imaging study

- Zubrod Performance Status 0-2

- History/physical examination within 2 weeks prior to registration

- Negative pregnancy test within 2 weeks prior to registration for women of
childbearing potential

- Women of childbearing potential and male participants who are sexually active must
agree to use a medically effective contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study

- MRI of the involved spine within 4 weeks prior to registration to determine the
extent of the spine involvement

- 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. Patients taking medication for pain at the time of registration are

- Neurological examination within 1 week prior to registration to rule out rapid
neurologic decline

Exclusion Criteria:

- Histology of myeloma, lymphoma or germ cell tumors.

- Non-ambulatory patients

- Spine instability due to a compression fracture

- > 50% loss of vertebral body height

- Frank spinal cord displacement or epidural involvement with> 25% encirclement of cord
or >25% spinal canal involvement.

- Prior radiation to the index spine

- Patients for whom an MRI of the spine is medically contraindicated

- Uncontrolled intercurrent illness

Type of Study:


Study Design:

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

Outcome Measure:

Pain Control as measured by NPRS

Outcome Description:

Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Anand Mahadevan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Isreal Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Primary Tumor
  • Metastatic Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Beth Israel Deacness Medical Center Boston, Massachusetts  02215