Clinical trial NCT01752036: Radiotherapy for Solid Tumor Spine Metastases
Official title: Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumor Spine Metastases
Keywords: stereotactic radiotherapy
SRS
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Post-Operative Stereotactic Radiosurgery
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 document.

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.

Primary outcomes:
measure: Number of Participants With Radiographic Recurrence at 12 Months
timeFrame: 1 year
measure: Time to Local Recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants Receiving Re-treatment
timeFrame: 1 year
measure: Number of Participants With Symptomatic Recurrence
timeFrame: 1 year
measure: Number of Participants Experiencing Radiation Myelopathy
timeFrame: 1 year
measure: Number of Participants Experiencing Wound Dehiscence
timeFrame: 1 year
measure: Time to Return to Chemotherapy
timeFrame: 1 year
measure: Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kristin Redmond, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redmond KJ, Sciubba D, Khan M, Gui C, Lo SL, Gokaslan ZL, Leaf B, Kleinberg L, Grimm J, Ye X, Lim M. A Phase 2 Study of Post-Operative Stereotactic Body Radiation Therapy (SBRT) for Solid Tumor Spine Metastases. Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):261-268. doi: 10.1016/j.ijrobp.2019.10.011. Epub 2019 Oct 16.