MAnagement of METastatic Disease in Campania (MAMETIC) (MAMETIC)

November 5, 2024 updated by: National Cancer Institute, Naples

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

3234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Campania
      • Napoli, Campania, Italy
        • Radioterapia Oncologica INT IRCCS- Fondazione G.Pascale Sede Centrale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with metastatic disease candidates for radiotherapy and resident in Campania region

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective Study: Occurrence of palliative radiotherapy treatments in the Campania region
Time Frame: 20 months (Interval from January 2019 to August 2020)
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
Time Frame: 60 months (Interval from September 2020 to September 2025)
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
Time Frame: 20 months (Interval from January 2019 to August 2020)
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 Frame: 20 months (Interval from January 2019 to August 2020)
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
Time Frame: 60 months (Interval from September 2020 to September 2025)
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 Frame: 60 months (Interval from September 2020 to September 2025)
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
Time Frame: 60 months (Interval from September 2020 to September 2025)
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
Time Frame: Up to 1 month after the end of RT
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).
Time Frame: Until 2 weeks before RT
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).
Time Frame: Until 2 weeks before RT
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).
Time Frame: Until 2 weeks before RT
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)
Time Frame: Until 2 weeks before RT
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.
Time Frame: Until 2 weeks before RT
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.
Time Frame: Until 2 weeks before RT
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Paolo Muto, MD, National Cancer Institute of Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

October 17, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33/20 oss

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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