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Stereotactic radiosurgery versus decompressive surgery followed by postoperative radiotherapy for metastatic spinal cord compression (STEREOCORD): Study protocol of a randomized non-inferiority trial.

ABSTRACT: Current treatment standard for patients with metastatic spinal cord compression (MSCC) is decompressive surgery followed by radiotherapy. Stereotactic radiosurgery (SRS) could be considered a treatment option for MSCC for patients with minor neurologic deficits. If SRS is safely and effectively delivered with equivalent functional outcome, the patients would avoid the risks associated with an invasive procedure. This paper presents the design of a non-inferiority clinical trial evaluating the safety, tolerability and feasibility of SRS vs. current standard treatment for patients with MSCC. Patients fulfilling inclusion criteria will be randomized 1:1 to each arm. The primary endpoint is ability to walk six weeks after treatment. Secondary endpoints are levels of pain, bladder control, quality of life, response rate, toxicity and number of treatment days. 65 patients in each arm are required for the power of 89% to detect a clinically relevant inferior outcome.

SUBMITTER: Suppli MH

PROVIDER: S-EPMC5658847 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Stereotactic radiosurgery versus decompressive surgery followed by postoperative radiotherapy for metastatic spinal cord compression (STEREOCORD): Study protocol of a randomized non-inferiority trial.

Suppli Morten H MH Af Rosenschold Per Munck PM Pappot Helle H Dahl Benny B Morgen Søren S SS Vogelius Ivan R IR Engelholm Svend A SA

Journal of radiosurgery and SBRT 20160101 1

Current treatment standard for patients with metastatic spinal cord compression (MSCC) is decompressive surgery followed by radiotherapy. Stereotactic radiosurgery (SRS) could be considered a treatment option for MSCC for patients with minor neurologic deficits. If SRS is safely and effectively delivered with equivalent functional outcome, the patients would avoid the risks associated with an invasive procedure. This paper presents the design of a non-inferiority clinical trial evaluating the sa ...[more]

PMID: 29296431

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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:Patient-reported outcomes (PRO) represent an important measure of cancer therapy effect. For patients with metastatic epidural spinal cord compression (MESCC), hybrid therapy using separation surgery and stereotactic radiosurgery preserves neurologic function and provides tumor control. There is currently a paucity of data reporting PRO after such combined modality therapy for MESCC. Delineation of hybrid surgery-radiosurgery therapy effect on PRO validates the hybrid approach as an effective therapy resulting in meaningful symptom relief. Patients and Methods:Brief Pain Inventory (BPI) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP), PROs validated in the cancer population, were prospectively collected. Patients with MESCC who underwent separation surgery followed by stereotactic radiosurgery were included. Separation surgery included a posterolateral approach without extensive cytoreductive tumor excision. A median postoperative radiosurgery dose of 2700 cGy was delivered. The change in PRO 3 months after the hybrid therapy represented the primary study outcome. Preoperative and postoperative evaluations were analyzed using the Wilcoxon signed-rank test for matched pairs. Results:One hundred eleven patients were included. Hybrid therapy resulted in a significant reduction in the BPI items "worst" and "right now" pain (P < .0001), and in all BPI constructs (severity, interference with daily activities, and pain experience, P < .001). The MDASI-SP demonstrated reduction in spine-specific pain severity and interference with general activity (P < .001), along with decreased symptom interference (P < .001). Conclusions:Validated PRO instruments showed that in patients with MESCC, hybrid therapy with separation surgery and radiosurgery results in a significant decrease in pain severity and symptom interference. These prospective data confirm the benefit of hybrid therapy for treatment of MESCC and should facilitate referral of patients with MESCC for surgical evaluation.

Project description:BackgroundSpinal stereotactic body radiation therapy (SBRT) is increasingly used to manage spinal metastases, yet the technique's effectiveness in controlling the symptom burden of spinal metastases has not been well described. We investigated the clinical benefit of SBRT for managing spinal metastases and reducing cancer-related symptoms.Methods149 patients with mechanically stable, non-cord-compressing spinal metastases (166 lesions) were given SBRT in a phase 1-2 study. Patients received a total dose of 27-30 Gy, typically in three fractions. Symptoms were measured before SBRT and at several time points up to 6 months after treatment, by the Brief Pain Inventory (BPI) and the M D Anderson Symptom Inventory (MDASI). The primary endpoint was frequency and duration of complete pain relief. The study is completed and is registered with ClinicalTrials.gov, number NCT00508443.FindingsMedian follow-up was 15·9 months (IQR 9·5-30·3). The number of patients reporting no pain from bone metastases, as measured by the BPI, increased from 39 of 149 (26%) before SBRT to 55 of 102 (54%) 6 months after SBRT (p<0·0001). BPI-reported pain reduction from baseline to 4 weeks after SBRT was clinically meaningful (mean 3·4 [SD 2·9] on the BPI pain-at-its-worst item at baseline, 2·1 [2·4] at 4 weeks; effect size 0·47, p=0·00076). These improvements were accompanied by significant reduction in opioid use during the first 6 months after SBRT (43 [28·9%] of 149 patients with strong opioid use at baseline vs 20 [20·0%] of 100 at 6 months; p=0·011). Ordinal regression modelling showed that patients reported significant pain reduction according to the MDASI during the first 6 months after SBRT (p=0·00003), and significant reductions in a composite score of the six MDASI symptom interference with daily life items (p=0·0066). Only a few instances of non-neurological grade 3 toxicities occurred: nausea (one event), vomiting (one), diarrhoea (one), fatigue (one), dysphagia (one), neck pain (one), and diaphoresis (one); pain associated with severe tongue oedema and trismus occurred twice; and non-cardiac chest pain was reported three times. No grade 4 toxicities occurred. Progression-free survival after SBRT was 80·5% (95% CI 72·9-86·1) at 1 year and 72·4% (63·1-79·7) at 2 years.InterpretationSBRT is an effective primary or salvage treatment for mechanically stable spinal metastasis. Significant reductions in patient-reported pain and other symptoms were evident 6 months after SBRT, along with satisfactory progression-free survival and no late spinal cord toxicities.FundingNational Cancer Institute of the US National Institutes of Health.

Project description:PurposeMetastatic epidural spinal cord compression (MESCC) is a devastating complication of advanced malignancy, which can result in neurologic complications and significant deterioration in overall function and quality of life. Most patients are not candidates for optimal surgical decompression and as a result, receive urgent 3D conformal radiotherapy (3DCRT) to prevent or attempt to reverse neurologic progression. Multiple trials indicate that response and ambulatory rates after 3DCRT are inferior to surgery. The advent of stereotactic body radiation therapy (SBRT) has created a method with which a "radiosurgical decompression" boost may facilitate improve outcomes for MESCC patients.MethodsWe are conducting a pilot study to investigate SBRT boost after urgent 3D CRT for patients with MESCC. The aim of the study is to establish feasibility of this two-phase treatment regimen, and secondarily to characterize post-treatment ambulation status, motor response, pain control, quality of life and survival.DiscussionWe describe the study protocol and present a case report of one patient. A quality assurance review was conducted after the first seven patients, and resultant dose-constraints were revised to improve safety and feasibility of planning through more conservative organ at risk constraints. There have been no severe adverse events (grade 3-5) to date. We have illustrated clinical and dosimetric data of an example case, where a patient regained full strength and ambulatory capacity.ConclusionsOur study aims to determine if SBRT is a feasible option in addition to standard 3DCRT for MESCC patients, with the goal to consider future randomized trials if successful. Having a robust quality assurance process in this study ensures translatability going forward if future trials with multicenter and increased patient representation are to be considered.Trial registrationclinicaltrials.gov; registration no. NCT03529708; https://clinicaltrials.gov/ct2/show/NCT03529708 ; First posted May 18, 2018.

Dataset Information

Stereotactic radiosurgery versus decompressive surgery followed by postoperative radiotherapy for metastatic spinal cord compression (STEREOCORD): Study protocol of a randomized non-inferiority trial.

Publications

Stereotactic radiosurgery versus decompressive surgery followed by postoperative radiotherapy for metastatic spinal cord compression (STEREOCORD): Study protocol of a randomized non-inferiority trial.

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