MAnagement of METastatic Disease In Campania (MAMETIC)

Study Overview
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Brief Summary
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The MAMETIC Trial represents the first regional epidemiological study that aims to evaluate patients living in Campania with metastatic cancer, with the intent to detect different prevalence of tumors in the metastatic phase and evaluate the local response to the patient's request for assistance. Condition or disease: Metastatic disease Intervention/treatment: Radiation Treatment

Detailed Description
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The MAMETIC Trial is a multicenter, retrospective and prospective observational study and 17 of 20 RT Centers in Campania joined it. The retrospective part of the study concerns all patients enrolled with a diagnosis of metastatic disease and treated in RT centers of the Campania Region with 3DCRT, IMRT, VMAT, SBRT techniques from January 2019 to August 2020. In 2019, it has been enrolled 12.500 patients in the 17 RT Centers and it is estimated that 20-30% of the above mentioned patients had metastasis. Thus, approximately 2.560 patients are expected to be enrolled. The prospective part of the study is going to enroll all metastatic patients eligible for palliative RT, treated in RT Centers of the Campania region with 3DCRT, IMRT, VMAT, SBRT techniques from September 2020 to September 2025. Considering the RT Centers that joined the trial, it is expected to enroll approximately 2.500-4.200 patients per year and a total of 12.500-21.000 patients in 5 years. The study will last 61 months, divided as follow: 60 months of enrollment phase and up to 1 month of follow-up for pain and bone metastasis patients. Follow-up will be performed on the 15th and 30th day after the end of radiation treatment.

Official Title
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MAnagement of METastatic Disease In Campania (MAMETIC): Role of Radiotherapy in an Italian Region: Protocol for an Observational Multicenter Trial

Conditions
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Metastatic Disease

Intervention / Treatment
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* Device: 3DCRT, IMRT, VMAT, SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged > 18 years resident in Campania Region; Patients diagnosed with metastatic disease candidates for radiotherapy Metastatic patients candidates for radiotherapy re-treatment Oligometastatic patients candidates for radiotherapy; Patients who have given their consent Exclusion Criteria: Patients aged < 18 years Patients who are unable to express consent to sensitive data and radiant treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 3DCRT, IMRT, VMAT, SBRT|Radiation treatment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective Study: Occurrence of palliative radiotherapy treatments in the Campania region | Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological Study) | 20 months (Interval from January 2019 to August 2020) | 
| Prospective Study: Occurrence of palliative radiotherapy treatments in the Campania region | Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological study) | 60 months (Interval from September 2020 to September 2025) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective Study: a. Incidence of metastatic disease at diagnosis | Incidence of metastatic disease at diagnosis | 20 months (Interval from January 2019 to August 2020) | 
| Retrospective Study: b. Time between first diagnosis and the onset of metastases | Time between first diagnosis and the onset of metastases | 20 months (Interval from January 2019 to August 2020) | 
| Prospective Study: Level A a. Incidence of metastatic disease at diagnosis | Incidence of metastatic disease at diagnosis | 60 months (Interval from September 2020 to September 2025) | 
| Prospective Study: Level A b. Time between first diagnosis and the onset of metastases | Time between first diagnosis and the onset of metastases | 60 months (Interval from September 2020 to September 2025) | 
| Prospective Study: Level A c. Interval from the first course of the radiation therapy to the retreatment | Interval from the first course of the radiation therapy to the retreatment (Epidemiological study) | 60 months (Interval from September 2020 to September 2025) | 
| Prospective Study: Level B a. Pain control | Pain control measured for patient self-reporting of pain with Numeric Rating Scale (NRS) score, a 11-point scale (from 0 to 10), with higher scores indicating greater pain intensity | Up to 1 month after the end of RT | 
| Prospective Study: Level C a. Quality of Life (QoL) according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire (health-related quality of life). | Quality of life (QoL) according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire (health-related quality of life). It is scored on a metric from 0 to 10, higher scores mean better outcome | Until 2 weeks before RT | 
| Prospective Study: Level C b. Functional performance measured by Palliative Performance Score (PPS). | Functional performance measured by Palliative Performance Score (PPS). To score, there are 11 levels of PPS from 0% to 100% in 10 percent increments. Every decrease in 10% marks a fairly significant decrease in physical function. | Until 2 weeks before RT | 
| Prospective Study: Level C c. Quality of life (QoL) of patients with bone metastases according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 questionnaire (health-related quality of life). | Quality of life (QoL) of patients with bone metastases according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 questionnaire (health-related quality of life). It is scored on a metric from 0 to 100. Higher scores mean better outcome. | Until 2 weeks before RT | 
| Prospective study: LEVEL C d. Incidence of spinal instability in patients with spinal metastases according to Spinal Instability Neoplastic Score (SINS) | Incidence of spinal instability in patients with spinal metastases according to Spinal Instability Neoplastic Score (SINS). It is scored from 0 to 18. Higher scores mean worse outcome. | Until 2 weeks before RT | 
| Prospective study: LEVEL C e. Evaluation of functional impairment as a result of their spinal cord injury according to the American Spinal Injury Association (ASIA) Score. | Evaluation of functional impairment as a result of their spinal cord injury according to the American Spinal Injury Association (ASIA) Score. It is scored from 0 to 324. Higher scores mean better outcome. | Until 2 weeks before RT | 
| Prospective study: LEVEL C f. Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination. | Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination. It is scored from 0 to 30. Higher scores mean better outcome. | Until 2 weeks before RT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Metastatic disease, Radiotherapy, Cancer pain, Breakthrough Cancer Pain, Quality of Life