MAnagement of METastatic Disease in Campania (MAMETIC): Role of Radiotherapy in an Italian Region: Protocol for an Observational Multicenter Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,234
- Locations
- 1
- Primary Endpoint
- Prospective Study: Occurrence of palliative radiotherapy treatments in the Campania region
Study Overview
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.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
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)
Secondary Outcomes
- 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).(Until 2 weeks before RT)
- Retrospective Study: b. Time between first diagnosis and the onset of metastases(20 months (Interval from January 2019 to August 2020))
- Retrospective Study: a. Incidence of metastatic disease at diagnosis(20 months (Interval from January 2019 to August 2020))
- Prospective Study: Level A c. Interval from the first course of the radiation therapy to the retreatment(60 months (Interval from September 2020 to September 2025))
- Prospective Study: Level C b. Functional performance measured by Palliative Performance Score (PPS).(Until 2 weeks before RT)
- Prospective Study: Level A a. 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(60 months (Interval from September 2020 to September 2025))
- Prospective Study: Level B a. Pain control(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).(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)(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.(Until 2 weeks before RT)
- Prospective study: LEVEL C f. Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination.(Until 2 weeks before RT)