Single Versus Multiple Fractionated SSRS for Spinal Metastases
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|ClinicalTrials.gov Identifier: NCT02608866|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Secondary Malignant Neoplasm of Spine||Radiation: SF-SSRS Radiation: MF-SSRS||Not Applicable|
Although conventionally fractionated radiation therapy has been utilized for decades, the rates of complete pain relief and local control for complex tumors are sub-optimal. The management of patients with spine metastasis has undergone a great deal of change in the past 5 years. Improvements in neuroimaging, computer-assisted treatment planning, and radiation therapy techniques have led to the development of extracranial radiosurgery.
SSRS is rapidly being adopted in the clinic as preliminary applications of SSRS appears promising. However, the role of SSRS remains in its infancy and lacked high-quality evidence about the treatment schedule and lacked a solid understanding of the adverse events. The Radiation Therapy Oncology Group (RTOG) 0631 phase 2/3 study was initiated to determine whether a more intensive radiation dose delivered by image guided 16-Gy dose single fraction SRS could improve pain control and quality of life as compared with conventional external-beam radiotherapy in patients with localized spine metastases . While other group used treatment schedule in a total dose of 27-30 Gy in three fractions.
Serious adverse events such as vertebral compression fracture (VCF) is a fairly low-risk adverse event after conventional radiotherapy, nevertheless, the crude risk estimates for VCF after spinal stereotactic body radiation therapy is relative more frequent. Previous reports has raised the caution about the given dose and predictive factors, however; whether these two most widely used SSRS schedule (ie. single fraction versus three fractions) provide equivalent pain control and minimal side effects remained to be answered.
There was no randomized trials to assess the SSRS treatment response and SSRS induced grade 3 or higher adverse events between the two most widely adopted scheme. Thus, the investigators proposed the randomized study to determine the feasibility of delivering a single 16-Gy SRS dose versus 3 fractions 24-Gy SRS dose and tried to evaluate the toxicity profile and gain robust data as well as predictive factors regarding the risk of complications after SSRS, including VCF. The investigators will incorporate the recently developed and reported reliable Spinal Instability Neoplastic Scoring (SINS) system and well-designed patient reported outcome measures (PROMs) into the protocol to predict the adverse event and quality of life of each participant. The researchers also tried to investigate the possible associations of the potential bone biomarkers for the risk assessment of SSRS-related adverse bone events.
Since the patients were randomized for treatment arms, the effectiveness of SSRS treatment scheme and adverse profile can be investigated more properly in the present study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Clinical Trial of Single Versus Multiple Fractionated Stereotactic Spine Radiosurgery for Patients With Spinal Metastases|
|Actual Study Start Date :||November 16, 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
Single-Fraction (SF) Stereotactic Spine Radiosurgery
Spine stereotactic radiosurgery/ablative radiotherapy (SSRS) with 16 Gy in single fraction to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc).
Multiple-Fraction (MF) Stereotactic Spine Radiosurgery
SSRS with 24 Gy in three fractions to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Treatment should be given on every other day. Treatment on the consecutive days to the same target volume is not allowed.
- Common Toxicity Criteria for Adverse Events version 4 Grade 3 or higher adverse events related to spine radiosurgery [ Time Frame: 16 weeks after SSRS ]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
- The pain response rate at the treated index site(s) at 4 months by the numerical rating pain scale [ Time Frame: 16 weeks after Stereotactic Spine Radiosurgery ]
- Health-related quality of life for palliative cancer care patients [ Time Frame: 1-, 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery ]European Organization for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire module and Quality of Life questionnaire for palliation
- Local control rate at the treated index site(s) [ Time Frame: 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 ]
- Acute toxicity (Common Toxicity Criteria for Adverse Events version 4) [ Time Frame: Within 90 days after Stereotactic Spine Radiosurgery ]
- Late toxicity (Common Toxicity Criteria for Adverse Events version 4) [ Time Frame: From 90 days after Stereotactic Spine Radiosurgery until the date of death from any cause, up to 60 months ]
- Changes of spinal cord function by Frankel's classification grading system for spine injury at 4 months [ Time Frame: 16 weeks after Stereotactic Spine Radiosurgery ]
- Tumor-related spinal instability by the Spinal Instability Neoplastic Score (SINS) at 4 months. [ Time Frame: 16 weeks after Stereotactic Spine Radiosurgery ]
- Osseous changes of the treated index site(s) on CT scan within 12 months [ Time Frame: 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery ]
- Genomic risk of radiation induced vertebral compression fracture [ Time Frame: At baseline ]Assessed by grading based on vertebral height loss
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608866
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Feng-Ming Hsu, MD||National Taiwan University Hospital|