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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
All participants received SBRT at 600 cGy x 5 fractions
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Number of Participants With Radiographic Recurrence at 12 Months
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.
Time frame: 1 year
Time to Local Recurrence
To estimate the time (in months) to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Time frame: 1 year
Number of Participants Receiving Re-treatment
To estimate the rate of re-treatment at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Time frame: 1 year
Number of Participants With Symptomatic Recurrence
To estimate the rate of symptomatic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Time frame: 1 year
Number of Participants Experiencing Radiation Myelopathy
Number of participants experiencing radiation myelopathy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
Time frame: 1 year
Number of Participants Experiencing Wound Dehiscence
Number of participants treated with a post-operative stereotactic radiosurgery boost for resected spine metastases, experiencing wound dehiscence.
Time frame: 1 year
Time to Return to Chemotherapy
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Time in months to return to chemotherapy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
Time frame: 1 year
Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence
To evaluate the post-treatment symptomatic local recurrence in patients with radio-sensitive tumors.
Time frame: 1 year