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. 2022 Apr 8:15:1003-1010.
doi: 10.2147/JPR.S336357. eCollection 2022.

Management of Metastatic Disease in Campania (MAMETIC): An Observational Multicenter Retrospective and Prospective Trial on Palliative Radiotherapy in an Italian Region. Study Protocol

Rossella Di Franco  1 , Marco Cascella  2 , Mario Fusco  3 , Valentina Borzillo  1 , Esmeralda Scipilliti  1 , Piera Ferraioli  1 , Eva Iannacone  1 , Giampaolo De Palma  1 , Giustino Silvestro  1 , Federica Gherardi  1 , Sergio Buonopane  1 , Domingo Alberti  1 , Giuseppe Totaro  1 , Roberto Manzo  1 , Giovanna Guida  1 , Arturo Cuomo  2 , Sandro Pignata  4 , Marilena Di Napoli  4 , Sabrina Rossetti  4 , Egidio Celentano  5 , Anna Crispo  5 , Maria Grimaldi  5 , Vincenzo Ravo  1 , Paolo Muto  1
Affiliations

Management of Metastatic Disease in Campania (MAMETIC): An Observational Multicenter Retrospective and Prospective Trial on Palliative Radiotherapy in an Italian Region. Study Protocol

Rossella Di Franco et al. J Pain Res. .

Abstract

Background: 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.

Methods: 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.

Conclusion: 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.

Keywords: breakthrough cancer pain; cancer pain; metastatic disease; palliative care; quality of life; radiotherapy.

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Conflict of interest statement

The authors declare that they have no competing interests in this work.

Figures

Figure 1
Figure 1
Flowchart of study design: Retrospective study consists of epidemiological analysis; prospective study consists of both epidemiological (level A, B and C), cancer pain assessment (level B and C) and patient’s quality of life (level C) analysis.
See this image and copyright information in PMC

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