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Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases

Phase 2
12 Years
Open (Enrolling)
Solid Tumor Spine Metastases

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Trial Information

Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases

This is a phase II trial evaluating the rate radiographic local recurrence following
post-operative stereotactic radiosurgery boost in patients with metastatic solid
malignancies with spine metastases status post resection. Patients will be treated with 600
cGy x 5 fractions to the tumor bed and then followed both clinically and radiographically to
determine if local recurrence following this treatment is better than might be expected for
conventional radiation therapy.

Inclusion Criteria:

- Age ≥12 years

- Histologically proven solid tumor malignancy with metastasis to the spine. Diagnosis
may be acquired from needle biopsy, cytology, or surgical biopsy or resection.

- Radiographic evidence of spinal metastasis is required and may be obtained from plain
radiographs, radionuclide bone scans, computed tomography imaging, and magnetic
resonance imaging. Other studies may be used with principal investigator approval.

- The patient must have undergone surgical resection resection (gross total, subtotal,
or biopsy) of the spinal lesion(s) no more than 12 weeks prior to SRS treatment.

- Treating physician must deem that SRS is appropriate treatment for the metastatic
spinal lesion(s).

- Each SRS target must be the equivalent of ≤3 vertebral levels

- The patient must have a Karnofsky Performance Score of 40 or greater

- If a woman is of child-bearing potential, a negative urine or serum pregnancy test
must be demonstrated prior to treatment. Women of childbearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) for the duration of study participation and for up to 12 weeks following
the study. Should a woman become pregnant or suspect she is pregnant while
participating in this study she should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Prior radiation or radiosurgery to the involved level of the spine

- Spine disease from leukemia, lymphoma or myeloma

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient
has been disease free for at least 1 year.

- Patients with uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements will be excluded.

- Pregnant and breastfeeding women are excluded. Women of child-bearing potential who
are unwilling or unable to use and acceptable method of birth control to avoid
pregnancy for the entire study period and up to 12 weeks after the study are
excluded. Male subjects must also agree to use effective contraception for the same
period as above.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of recurrence at 12 months

Outcome Description:

To estimate the rate of radiographic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Kristin Redmond, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

Related Keywords:

  • Solid Tumor Spine Metastases
  • stereotactic radiotherapy
  • SRS
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Neoplasms



The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231