Clinical trial NCT04595032: MAnagement of METastatic Disease in Campania (MAMETIC)
Official title: MAnagement of METastatic Disease in Campania (MAMETIC): Role of Radiotherapy in an Italian Region: Protocol for an Observational Multicenter Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Disease
Keywords: Palliative care
Metastatic disease
Radiotherapy
Cancer pain
Breakthrough Cancer Pain
Quality of Life
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 3234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with metastatic disease candidates for radiotherapy and resident in Campania region

Brief summary: 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: The MAMETIC Trial is a multicenter, retrospective and prospective observational study and 17 of 20 RT Centers in Campania joined it.

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retrospective Study: Occurrence of palliative radiotherapy treatments in the Campania region
timeFrame: 20 months (Interval from January 2019 to August 2020)
measure: Prospective Study: Occurrence of palliative radiotherapy treatments in the Campania region
timeFrame: 60 months (Interval from September 2020 to September 2025)
Secondary outcomes:
measure: Retrospective Study: a. Incidence of metastatic disease at diagnosis
timeFrame: 20 months (Interval from January 2019 to August 2020)
measure: Retrospective Study: b. Time between first diagnosis and the onset of metastases
timeFrame: 20 months (Interval from January 2019 to August 2020)
measure: Prospective Study: Level A a. Incidence of metastatic disease at diagnosis
timeFrame: 60 months (Interval from September 2020 to September 2025)
measure: Prospective Study: Level A b. Time between first diagnosis and the onset of metastases
timeFrame: 60 months (Interval from September 2020 to September 2025)
measure: Prospective Study: Level A c. Interval from the first course of the radiation therapy to the retreatment
timeFrame: 60 months (Interval from September 2020 to September 2025)
measure: Prospective Study: Level B a. Pain control
timeFrame: Up to 1 month after the end of RT
measure: 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).
timeFrame: Until 2 weeks before RT
measure: Prospective Study: Level C b. Functional performance measured by Palliative Performance Score (PPS).
timeFrame: Until 2 weeks before RT
measure: 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).
timeFrame: Until 2 weeks before RT
measure: Prospective study: LEVEL C d. Incidence of spinal instability in patients with spinal metastases according to Spinal Instability Neoplastic Score (SINS)
timeFrame: Until 2 weeks before RT
measure: 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.
timeFrame: Until 2 weeks before RT
measure: Prospective study: LEVEL C f. Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination.
timeFrame: Until 2 weeks before RT
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Radioterapia Oncologica INT IRCCS- Fondazione G.Pascale Sede Centrale
state: Campania
Study officials:
affiliation: National Cancer Institute of Naples
name: Paolo Muto, MD
role: PRINCIPAL_INVESTIGATOR
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