Secondary Malignant Neoplasm of Spine Clinical Trial
Official title:
A Prospective Randomized Clinical Trial of Single Versus Multiple Fractionated Stereotactic Spine Radiosurgery for Patients With Spinal Metastases
Verified date | March 2019 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators proposed this randomized study to determine the feasibility of delivering single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate their toxicity profiles. The investigators' analysis will provide robust data as well as predictive factors regarding the outcome after SSRS.
Status | Active, not recruiting |
Enrollment | 68 |
Est. completion date | August 2020 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion criteria To be eligible for inclusion, patients must fulfill the following criteria: 1. Patients with a histologic diagnosis of non-hematopoietic malignancy 2. Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion 3. Maximum three separate sites with a maximal involvement of two continuous vertebral levels 4. Patients do not have prior radiotherapy to the index spine(s) 5. Patients with metastatic epidural spinal cord compression (= grade 2) at the index spine(s) who will not be treated with spine surgery after evaluation by neurosurgeon or orthopedic doctor 6. Age = 20 years 7. Karnofsky performance status (KPS) = 60%. 8. Life expectancy of = 4 month. 9. Women of childbearing potential and male participants must practice adequate contraception 10. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent Exclusion criteria Patients fulfill any of the following criteria will be excluded from this trial 1. Prior radiotherapy to the index spine(s) 2. Serum creatinine > 2.0 mg/dL within 90 days prior registration 3. Contraindication to MRI such as implanted metal devices or foreign bodies, severe claustrophobia 4. Patients with leptomeningeal involvement or intramedullary metastasis 5. Inability to tolerate treatment procedure 6. Bony retropulsion causing neurologic abnormality 7. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows: - Uncontrolled active infection requiring intravenous antibiotics at the time of registration - Transmural myocardial infarction = 6 months prior to registration - Unstable angina or congestive heart failure requiring hospitalization = 6 months prior to registration - Life-threatening uncontrolled clinically significant cardiac arrhythmias - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration - Uncontrolled psychiatric disorder 8. Will receive any other investigational agent or chemotherapy and/or target therapies during treatment 9. Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Genomic risk of radiation induced vertebral compression fracture | Assessed by grading based on vertebral height loss | At baseline | |
Primary | Common Toxicity Criteria for Adverse Events version 4 Grade 3 or higher adverse events related to spine radiosurgery | The rate of 4-month Common Toxicity Criteria for Adverse Events version 4 grade 3 or higher adverse events definitely, probably or possibly related to treatment | 16 weeks after SSRS | |
Secondary | The pain response rate at the treated index site(s) at 4 months by the numerical rating pain scale | 16 weeks after Stereotactic Spine Radiosurgery | ||
Secondary | Health-related quality of life for palliative cancer care patients | European Organization for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire module and Quality of Life questionnaire for palliation | 1-, 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery | |
Secondary | Local control rate at the treated index site(s) | From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 60 months | ||
Secondary | Acute toxicity (Common Toxicity Criteria for Adverse Events version 4) | Within 90 days after Stereotactic Spine Radiosurgery | ||
Secondary | Late toxicity (Common Toxicity Criteria for Adverse Events version 4) | From 90 days after Stereotactic Spine Radiosurgery until the date of death from any cause, up to 60 months | ||
Secondary | Changes of spinal cord function by Frankel's classification grading system for spine injury at 4 months | 16 weeks after Stereotactic Spine Radiosurgery | ||
Secondary | Tumor-related spinal instability by the Spinal Instability Neoplastic Score (SINS) at 4 months. | 16 weeks after Stereotactic Spine Radiosurgery | ||
Secondary | Osseous changes of the treated index site(s) on CT scan within 12 months | 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04033536 -
Involved Versus Elective Target SSRS for Spinal Metastases
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N/A |