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临床试验/NCT03554135
NCT03554135Unknown不适用

SAINT: Single frActIoN eighT Gray Palliative Radiotherapy With Modulated Intensity for Pain Reduction: a Single Arm Cohort Analysis

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 50 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Pain control

研究概览

简要总结

Non-randomized, monocentric, observational study to evaluate the response in terms of reduction of painful symptoms from bone metastases to radiotherapy with high personalization of treatment: performed with modern technology, supplied with modulated intensity technique with concomitant integrated boost, according to selection of patients in accordance with prognosis determined by specific prognostic score

详细描述

Palliative antalgic oncological treatments concern a chronically-evolving disease patient with pain control problems, and are a complex problem from different points of view: logistic, clinical and scientific research. An increasing number of patients are afflicted due to the increased incidence of cancer in all its phases and the potential chronicity of the disease linked to new therapies.

The use of palliative anti-radiation radiotherapy treatments involves up to 40% of patients in a Radiotherapy Center. Radiotherapy was used in the palliative treatment of symptomatic bone metastases to improve quality of life (QoL) of these patients. This is the easiest way to respond to problems of home care or long-term care (eg: Hospice). This need is particularly accentuated for patients with a more severe situation. To reduce the overall duration of the treatment, it is necessary to manage hypofractionated regulators (ie with dose fractionation which daily dispense a dose higher than 2Gy). In fact, hypofractionated regimes concern the gold standard for these clinical presentations.

With the same pain control, multiple fractionation boards report better symptom control over time and are therefore very often preferred for patients with a prognosis> 6 months. On the other hand, the treatment regimen with 8 Gy in single therapy session is suggested as preferable for patients with a worse prognosis (ie less than 6 months of life expectancy). Evidence from literature suggests that palliative radiation therapy is effective in controlling pain even in the last weeks of the patient's life and therefore useful to improve the conditions of patients with a more severe prognosis.

The identification of patients with the worst prognosis to which single-agent radiotherapy is reserved is another crucial aspect. Unfortunately, although clinically validated in scientific trials, the routine use of prognostic scores is rarely used in everyday clinical practice to characterize life expectancy and define the most appropriate treatment regimen. This aspect limits the effective personalization of palliative treatments of this type.

Furthermore, the indications available in the literature do not specify a univocally shared standard of technical approach to radiant treatment. The Consensus Conference whose data have been reported by Chow et al. considers as potentially applicable both non-conformed techniques (e.g .: single back beam) and the most modern conformational techniques. The less conformed techniques have the defect of distributing in a more variable way the dose inside the target to irradiate and to save less well the organs at risk (OAR) with consequent increase of the risk of toxicity that could reduce the beneficial to the patient given by the reduction of pain from metastases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with spinal bone metastases from solid, uncomplicated tumor
  • Established primary or secondary tumor histology correlated to the treatment lesion
  • Age >18 years
  • Obtaining informed consent
  • Symptomatic patients (NRS> = 4) at the treatment site
  • Prognosis <6 months according to Mizumoto Prognostic Score (i.e. Class B or C)
  • Spine Instability Neoplastic Score (SINS) <7

排除标准

  • Concurrent disorders (psychiatric and otherwise) which, in the opinion of the investigator, make data collection unreliable
  • Impossibility to assign specific NRS for each CTV to be enrolled
  • Previous radiotherapy at the same site or at the level of adjoining metamers (higher or lower than the one to be enrolled)
  • Radiometabolic therapy
  • Previous enrollment of the same patient for 3 irradiated lesions
  • Epidural compression of the spinal cord or of the cauda equina
  • Injuries affecting> 25% of the medullary canal and / or a distance <5 mm from the medulla or from the cauda
  • Injuries with indication of surgical stabilization
  • Pregnancy

结局指标

主要结局

Pain control

时间窗: 1 month after end of radiotherapy

Pain control measured with Numeric Rating Scale (NRS) score, a 11-point scale for patient self-reporting of pain. NRS score presents a total range between 0 (no pain) and 10 maximum pain. NRS subscale are the sequent: * 0: no pain * 1-3: mild pain * 4-6: moderate pain * 7-10 severe pain

次要结局

  • Re-treatment during follow up(12 months after end of radiotherapy)
  • Pain-dipendent variables(12 months after end of radiotherapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Cellini

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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