Radiotherapy for Solid Tumor Spine Metastases

Completed · Phase 2

Conditions studied: Solid Tumor Spine Metastases

In brief

Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. The primary objective of this study is to evaluate radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared to the expected rate following conventional radiation therapy.

Key facts

Study ID

NCT01752036

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

35

Starts

2013-05-20

Expected to finish

2018-07-27

Last updated by the study team

2020-06-25

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 document.

You may not qualify if…

• 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.

Where it is running

• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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