Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
spinal cord metastases, unspecified adult solid tumor, protocol specific, pain
Brief summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis. PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.
Detailed description
OBJECTIVES: Primary * To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3 months in patients with localized spinal metastasis. Secondary * To determine the duration of pain response at the treated site(s) scored as the time of maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System. * To determine the functional preservation of improvement as measured by the Brief Pain Inventory. * To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires. * To determine the long-term stability of the treated vertebral bone (e.g., fracture, sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan, and plain radiographs. OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to the planned treatment site(s). * Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. * Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90 minutes. Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous vertebroplasty. Patients complete pain and quality-of-life questionnaires at baseline and periodically during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and then every 6 months for 3 years to assess changes in vertebral bone strength and stability. After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months, and then every 6 months for 3 years.
Interventions
RADIATIONradiation
Given in 1 or 5 fractions
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility: Inclusion: * Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted) * Patients must have a VAS of ≥4 at any of the planned treatment sites * Patient with epidural, spinal nerve, and/or cord compression on MRI may be included * Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy * Narcotic pain prescription and usage information must be available and documented * Patients must sign study specific consent * Above the age of 18 * For women of childbearing age a negative pregnancy test is required * Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment * Zubrod score of 0-2 Exclusion: * Patients who have been non-ambulatory for more than 7 days * Patients with compression fractures * Spine instability requiring fixation * Patients with paraspinal extension * Patients with bony fragments * Planned systemic treatment within one week after treatment. * Absence of pathological diagnosis of cancer * Chemotherapy within one week of treatment * Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma * Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Patient had a transmural myocardial infarction within the last 6 months * Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy * PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy * Platelet count is \< 50,000 * History of significant psychiatric illness Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Response as Measured by VAS at 3 Months | 3 month | Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Response | 1 month | Duration of pain response as measured by VAS at 1 month Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response |
| Overall Survival | 5 year | Overall survival measured from the date of accession to the date of death. Median times will be reported. |
| Daily Function | Baseline | Time to functional decline as measure by the Brief Pain Inventory (BPI) at baseline. BPI has two sections that are scored- pain severity and pain interference. For each of these a numeric scale from 0-10 is used, with 0 being the worst pain and 10 being the worst pain. |
| Quality of Life Questionnaire Responses | 12 months | Number of participants who filled out the Functional Assessment of Cancer Therapy- General (FACT-G) and the European Quality of Life Five Dimension (EQ-5D) questionnaires at baseline, 1, 3, 6, and 12 months |
Countries
United States
Participant flow
Recruitment details
3 withdrew before starting treatment, 1 had clinical decline prior to treatment and was removed, 1 was removed prior to treatment for local progression, and 1 was removed due to a pre-existing compression fracture prior to treatment, These 6 patients did start the study but were assessed for other outcomes.
Participants by arm
| Arm | Count |
|---|---|
| Total Population All patients enrolled to the study | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Not evaluable at 3 month timepoint | 2 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Technical inability to undergo procedure | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Total Population |
|---|---|
| Age, Continuous | 60 years |
| Number of vertebrae treated 1 | 23 participants |
| Number of vertebrae treated 2 | 6 participants |
| Preexisting endplate fracture No | 24 participants |
| Preexisting endplate fracture Yes | 5 participants |
| Primary Site Breast | 4 participants |
| Primary Site Colorectal | 2 participants |
| Primary Site Kidney | 4 participants |
| Primary Site Lung | 10 participants |
| Primary Site Melanoma | 3 participants |
| Primary Site Oropharyngeal | 1 participants |
| Primary Site Prostate | 4 participants |
| Primary Site Thyroid | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 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 | 27 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 19 Participants |
| Spine Location Cervical | 4 participants |
| Spine Location Lumbar | 13 participants |
| Spine Location Thoracic | 12 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 29 |
| other Total, other adverse events | 3 / 29 |
| serious Total, serious adverse events | 1 / 29 |
Outcome results
Primary
Pain Response as Measured by VAS at 3 Months
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response
Time frame: 3 month
Population: Patients who were evaluable at the 3-month timepoint
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Population | Pain Response as Measured by VAS at 3 Months | Patients with a partial pain response at 3 months | 8 Participants |
| Total Population | Pain Response as Measured by VAS at 3 Months | Patients with a complete pain response at 3 months | 12 Participants |
| Total Population | Pain Response as Measured by VAS at 3 Months | Patients without a pain response | 1 Participants |
Secondary
Daily Function
Time to functional decline as measure by the Brief Pain Inventory (BPI) at baseline. BPI has two sections that are scored- pain severity and pain interference. For each of these a numeric scale from 0-10 is used, with 0 being the worst pain and 10 being the worst pain.
Time frame: Baseline
Population: Patients enrolled to the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Population | Daily Function | Pain Severity | 5.8 score on a scale | Standard Deviation 1.8 |
| Total Population | Daily Function | Pain Interference | 6.0 score on a scale | Standard Deviation 2.2 |
Secondary
Overall Survival
Overall survival measured from the date of accession to the date of death. Median times will be reported.
Time frame: 5 year
Population: Patients who received spine SABR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Population | Overall Survival | 9 months |
Secondary
Pain Response
Duration of pain response as measured by VAS at 1 month Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response
Time frame: 1 month
Population: Patients who were evaluable at the 1 month timepoint
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Population | Pain Response | Patients with a complete pain response | 10 Participants |
| Total Population | Pain Response | Patients with a partial pain response | 10 Participants |
| Total Population | Pain Response | Patients with no pain response | 5 Participants |
Secondary
Quality of Life Questionnaire Responses
Number of participants who filled out the Functional Assessment of Cancer Therapy- General (FACT-G) and the European Quality of Life Five Dimension (EQ-5D) questionnaires at baseline, 1, 3, 6, and 12 months
Time frame: 12 months
Population: Enrolled participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Population | Quality of Life Questionnaire Responses | Number of responses at 12 months | 7 participant responses |
| Total Population | Quality of Life Questionnaire Responses | Number of responses at baseline | 35 participant responses |
| Total Population | Quality of Life Questionnaire Responses | Number of responses at 1 month | 29 participant responses |
| Total Population | Quality of Life Questionnaire Responses | Number of responses at 3 months | 21 participant responses |
| Total Population | Quality of Life Questionnaire Responses | Number of responses at 6 months | 16 participant responses |