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Premature Termination of a Randomized Controlled Trial on Image-Guided Stereotactic Body Radiotherapy of Metastatic Spinal Cord Compression.

ABSTRACT: LESSONS LEARNED:It is possible to plan and treat some patients with stereotactic body radiotherapy (SBRT) in a timely fashion in an acute setting. Advanced and, in some indications, already implemented technologies such as SBRT are difficult to test in a randomized trial. BACKGROUND:Stereotactic body radiotherapy (SBRT) in metastatic spinal cord compression (MSCC) could be an alternative to decompressive surgery followed by fractionated radiotherapy. METHODS:In a randomized, single-institution, noninferiority trial, patients with MSCC were assigned to stereotactic body radiotherapy of 16 Gy in 1 fraction or decompression surgery followed by fractionated radiotherapy of 30 Gy in 10 fractions. Primary endpoint was ability to walk by EQ5D-5L questionnaire. Based on power calculations, 130 patients had to be included to be 89% sure that a 15% difference between the treatment arm and the experimental arm could be detected. RESULTS:Ten patients were accrued in 23 months, with six patients allocated to surgery and four patients to stereotactic body radiotherapy. The trial was closed prematurely because of poor accrual. One patient undergoing surgery and one patient undergoing stereotactic body radiotherapy were unable to walk at 6?weeks. Two patients were not evaluable at 6?weeks. CONCLUSION:A randomized, phase II, clinical trial comparing surgery followed by fractionated radiotherapy or image-guided SBRT of MSCC was initiated. SBRT was shown to be feasible, with three out of four patients retaining walking function. The trial was determined futile as a result of low accrual.

SUBMITTER: Suppli MH

PROVIDER: S-EPMC7066690 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Premature Termination of a Randomized Controlled Trial on Image-Guided Stereotactic Body Radiotherapy of Metastatic Spinal Cord Compression.

Suppli Morten Hiul MH Munck Af Rosenschold Per P Dahl Benny B Berthelsen Anne Kiil AK Engelholm Svend Aage SA Pappot Helle H

The oncologist 20191011 3

<h4>Lessons learned</h4>It is possible to plan and treat some patients with stereotactic body radiotherapy (SBRT) in a timely fashion in an acute setting. Advanced and, in some indications, already implemented technologies such as SBRT are difficult to test in a randomized trial.<h4>Background</h4>Stereotactic body radiotherapy (SBRT) in metastatic spinal cord compression (MSCC) could be an alternative to decompressive surgery followed by fractionated radiotherapy.<h4>Methods</h4>In a randomized ...[more]

PMID: 32162821

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Project description:IntroductionSpinal metastasis is the most common metastatic skeletal disease in cancer patients. Metastatic epidural spinal cord compression (MESCC), which occurs in 5-14% of cancer patients, is an oncological emergency because it may cause a permanent neurological deficit. Separation surgery followed by stereotactic ablative radiotherapy (SABR), so-called "hybrid therapy," has shown effectiveness in local control of spinal metastasis and has become an integral treatment option for patients with MESCC. Therefore, we performed a meta-analysis and meta-regression analysis to clarify the local progression rate of hybrid therapy and the risk factors for local progression.MethodsWe searched PubMed, EMBASE, Scopus, Cochrane Library, and Web of Science databases from inception to December 2021. Meta-analyses of proportions were used to analyze the data using a random-effects model to calculate the pooled 1-year local progression rate and confidence interval. Subgroup analyses were performed using meta-analyses of odds ratio (OR) for comparisons between groups. We also conducted a meta-regression analysis to identify the factors that caused heterogeneity.ResultsA total of 661 patients from 13 studies (10 retrospective and 3 prospective) were included in the final meta-analysis. The quality of the included studies assessed using the Newcastle - Ottawa scale ranged from poor to fair (range, 4-6). The pooled local progression rate was 10.2 % (95 % confidence interval [CI], 7.8-12.8 %; I2 = 30 %) and 13.7 % (95 % CI, 9.3-18.8 %; I2 = 55 %) at postoperative 1 and 2 years, respectively. The subgroup analysis indicated that patients with a history of prior radiotherapy (OR, 5.14; 95 % CI, 1.71-15.51) and lower radiation dose per fraction (OR, 4.57; 95 % CI, 1.88-11.13) showed significantly higher pooled 1-year local progression rates. In the moderator analysis, the 1-year local progression rate was significantly associated with the proportion of patients with a history of prior radiotherapy (p = 0.036) and those with colorectal cancer as primary origin (p < 0.001).ConclusionsThe pooled 1-year local progression rate of hybrid therapy for MESCC was 10.2%. In subgroup and moderator analyses, a lower radiation dose per fraction, history of prior radiotherapy, and colorectal cancer showed a significant association with the 1-year local progression rate.

Project description:Background Magnetic resonance imaging (MRI) is currently used for online target monitoring and plan adaptation in modern image-guided radiotherapy. However, storing a large amount of data accumulated during patient treatment becomes an issue. In this study, the feasibility to compress MRI images accumulated in MR-guided radiotherapy using video encoders was investigated. Methods Two sorting algorithms were employed to reorder the slices in multiple MRI sets for the input sequence of video encoder. Three cropping algorithms were used to auto-segment regions of interest for separate data storage. Four video encoders, motion-JPEG (M-JPEG), MPEG-4 (MP4), Advanced Video Coding (AVC or H.264) and High Efficiency Video Coding (HEVC or H.265) were investigated. The compression performance of video encoders was evaluated by compression ratio and time, while the restoration accuracy of video encoders was evaluated by mean square error (MSE), peak signal-to-noise ratio (PSNR), and video quality matrix (VQM). The performances of all combinations of video encoders, sorting methods, and cropping algorithms were investigated and their effects were statistically analyzed. Results The compression ratios of MP4, H.264 and H.265 with both sorting methods were improved by 26% and 5%, 42% and 27%, 72% and 43%, respectively, comparing to those of M-JPEG. The slice-prioritized sorting method showed a higher compression ratio than that of the location-prioritized sorting method for MP4 (P=0.00000), H.264 (P=0.00012) and H.265 (P=0.00000), respectively. The compression ratios of H.265 were improved significantly with the applications of morphology algorithm (P=0.01890 and P=0.00530), flood-fill algorithm (P=0.00510 and P=0.00020) and level-set algorithm (P=0.02800 and P=0.00830) for both sorting methods. Among the four video encoders, H.265 showed the best compression ratio and restoration accuracy. Conclusions The compression ratio and restoration accuracy of video encoders using inter-frame coding (MP4, H.264 and H.265) were higher than that of video encoders using intra-frame coding (M-JPEG). It is feasible to implement video encoders using inter-frame coding for high-performance MRI data storage in MR-guided radiotherapy.

Project description:For metastatic spinal cord compression (MSCC), conventional radiotherapy with 10?×?3 Gy in 2 weeks results in better local progression-free survival (LPFS) than 5?×?4 Gy in 1 week. Since patients with MSCC are often significantly impaired, an overall treatment time of 1 week would be preferable if resulting in similar outcomes as longer programs. This may be achieved with 5?×?5 Gy in 1 week, since the biologically effective dose is similar to 10?×?3 Gy. It can be expected that 5?×?5 Gy (like 10?×?3) Gy results in better LPFS than 5?×?4 Gy in 1 week.This phase 2 study investigates LPFS after high-precision RT with 5?×?5 Gy in 1 week. LPFS is defined as freedom from both progression of motor deficits during RT and new or progressive motor deficits dur to an in-field recurrence of MSCC following RT. Considering the tolerance dose of the spinal cord, 5?×?5 Gy can be safely administered with high-precision radiotherapy such as volumetric modulated arc therapy (VMAT) or stereotactic body radiotherapy (SBRT). Maximum dose to the spinal cord should not exceed 101.5% of the prescribed dose to keep the risk of radiation myelopathy below 0.03%. Primary endpoint is LPFS at 6 months following radiotherapy; secondary endpoints include motor function/ability to walk, sensory function, sphincter dysfunction, LPFS directly and 1 and 3 months following radiotherapy, overall survival, pain relief, quality of life and toxicity. Follow-up visits will be performed directly and at 1, 3 and 6 months following radiotherapy. After completion of this phase 2 study, patients will be compared to a historical control group receiving conventional radiotherapy with 5?×?4 Gy in 1 week. Forty-four patients will be included assuming 5?×?5 Gy will provide the same benefit in LPFS when compared to 5?×?4 Gy as reported for 10?×?3 Gy.If superiority regarding LPFS is shown for high-precision radiotherapy with 5?×?5 Gy when compared to conventional radiotherapy with 5?×?4 Gy, patients with MSCC would benefit from 5?×?5 Gy, since high LPFS rates could be achieved with 1 week of radiotherapy instead of 2 weeks (10?×?3 Gy).clinicaltrials.gov NCT03070431 . Registered 27 February 2017.

Dataset Information

Premature Termination of a Randomized Controlled Trial on Image-Guided Stereotactic Body Radiotherapy of Metastatic Spinal Cord Compression.

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Premature Termination of a Randomized Controlled Trial on Image-Guided Stereotactic Body Radiotherapy of Metastatic Spinal Cord Compression.

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