Solid Tumor Spine Metastases
Conditions
Keywords
stereotactic radiotherapy, SRS
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.
Interventions
RADIATIONPost-operative, Stereotactic Body Radiation Therapy (SBRT)
All participants received SBRT at 600 cGy x 5 fractions
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Post-Operative Stereotactic Radiosurgery
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radiographic Recurrence at 12 Months | 1 year | 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 to Local Recurrence | 1 year | To estimate the time (in months) to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Radiation Myelopathy | 1 year | Number of participants experiencing radiation myelopathy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases |
| Number of Participants Experiencing Wound Dehiscence | 1 year | Number of participants treated with a post-operative stereotactic radiosurgery boost for resected spine metastases, experiencing wound dehiscence. |
| Number of Participants Receiving Re-treatment | 1 year | To estimate the rate of re-treatment at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases |
| Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence | 1 year | To evaluate the post-treatment symptomatic local recurrence in patients with radio-sensitive tumors. |
| Time to Return to Chemotherapy | 1 year | Time in months to return to chemotherapy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases. |
| Number of Participants With Symptomatic Recurrence | 1 year | 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 |
Countries
United States
Participant flow
Pre-assignment details
33 of the 35 enrolled participants received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Post-operative, Stereotactic Body Radiation Therapy (SBRT): All participants received SBRT at 600 cGy x 5 fractions | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 63 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 35 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 33 |
| other Total, other adverse events | 31 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Radiographic Recurrence at 12 Months | 3 Participants |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Time to Local Recurrence | 3.5 months |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Experiencing Radiation Myelopathy | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Experiencing Wound Dehiscence | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Receiving Re-treatment | 2 Participants |
Secondary
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
Population: Only 3 participants had radio-sensitive tumors.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Radio-sensitive Tumors Who Had Symptomatic Local Recurrence | 3 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Symptomatic Recurrence | 31 Participants |
Secondary
Time to Return to Chemotherapy
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Time to Return to Chemotherapy | 0.5 months |