Di Franco Rossella, Cascella Marco, Fusco Mario, Borzillo Valentina, Scipilliti Esmeralda, Ferraioli Piera, Iannacone Eva, De Palma Giampaolo, Silvestro Giustino, Gherardi Federica, Buonopane Sergio, Alberti Domingo, Totaro Giuseppe, Manzo Roberto, Guida Giovanna, Cuomo Arturo, Pignata Sandro, Di Napoli Marilena, Rossetti Sabrina, Celentano Egidio, Crispo Anna, Grimaldi Maria, Ravo Vincenzo, Muto Paolo
Department of Radiation Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli, Italia.
Division of Anesthesia and Pain Medicine, Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Napoli, Italia.
J Pain Res. 2022 Apr 8;15:1003-1010. doi: 10.2147/JPR.S336357. eCollection 2022.
In the Italian Campania Region, 30.517 new cases of solid cancer have been diagnosed, in 2019. Of those, patients with metastatic disease are up to 20%. This class of patients is extremely diversified and copious, and the offer of radiotherapy may vary in different geographical areas within the same region. The aim of this observational multicenter retrospective and prospective trial is to evaluate the occurrence of metastatic metastatic cancer patients candidates for palliative radiotherapy in several areas of a great Italian region, the management of the disease through RT approaches, and its impact on cancer-related pain and overall HRQoL.
This is a multicenter, retrospective and prospective observational investigation. The retrospective part of the study concerns all patients enrolled with a diagnosis of metastatic disease and treated in RT centers within the Campania Region between January 2019 and July 2020. The prospective phase is going to involve all the metastatic patients with an indication of palliative RT. Considering regional epidemiological data, we expect an enrollment of 12.500-21.000 patients in 5 years.
The MAMETIC Trial in an observational study designed for investigating on the use of radiotherapy in patients with advanced disease within a regional area, and for evaluating the local response to the patient's request. It can be a unique opportunity, not only to highlight possible geographic differences but also to regularly collect and share data to standardize the therapeutic offer within the regional area. ClinicalTrials.gov ID NCT04595032, retrospectively registered.
2019年，意大利坎帕尼亚地区确诊了30517例实体癌新病例。其中，转移性疾病患者占比高达20%。这类患者极为多样化且数量众多，同一地区不同地理区域的放射治疗服务可能存在差异。这项多中心观察性回顾性和前瞻性试验的目的是评估意大利一个大区多个地区中适合姑息性放疗的转移性癌症患者的情况、通过放疗方法对疾病的管理及其对癌症相关疼痛和总体健康相关生活质量的影响。
这是一项多中心回顾性和前瞻性观察性研究。研究的回顾部分涉及2019年1月至2020年7月期间在坎帕尼亚地区放疗中心登记诊断为转移性疾病并接受治疗的所有患者。前瞻性阶段将纳入所有有姑息性放疗指征的转移性患者。考虑到区域流行病学数据，我们预计5年内将招募12500 - 21000名患者。
MAMETIC试验是一项观察性研究，旨在调查区域内晚期疾病患者放疗的使用情况，并评估对患者需求的局部反应。这不仅是突出可能存在的地理差异的独特机会，也是定期收集和共享数据以规范区域内治疗服务的独特机会。ClinicalTrials.gov标识符NCT04595032，回顾性注册。
