MAnagement of METastatic Disease In Campania (MAMETIC)

Metastatic Disease Clinical Trial

— MAMETIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595032
• Other study ID #: 33/20 oss
• Status: Completed
• Start date: September 11, 2020
• Est. completion date: February 8, 2024

Study information

• Verified date: June 2024
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3234
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Disease
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Device:
• 3DCRT, IMRT, VMAT, SBRT
Radiation treatment

Locations

Country	Name	City	State
Italy	Radioterapia Oncologica INT IRCCS- Fondazione G.Pascale Sede Centrale	Napoli	Campania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (38)

16. Giugliano FM, Di Franco R, Iadanza L, Borzillo V, Cutillo L and Muto P. Elderly Patients with Painful Bone Metastases. The Impact of Comorbidity on the Choice of Radiation Therapy Regimen. Journal of Palliative Care & Medicine

17. Di Franco R, Falivene S, Ravo V, Borzillo V, Giugliano FM, Argenone A, Rossetti S, Cavaliere C, D'aniello C, Romano FJ, Berretta M, Facchini G, Muto P. Impact of Procedural Pain In Radiotherapy Treatment WCRJ 2017; 4 (2): e884

18. Di Franco R, Calvanese M, Cuomo M, Manzo R, Murino P, Cappabianca S, Ravo V. Management of Painful Bone Metastases: The Interaction between Radiation Therapy and Zoledronate Journal of Cancer Therapy, 2011, 2, Published Online December 2011

28. Borzillo V, Giugliano FM, Di Franco R, Falivene S, Cammarota F, Ravo V, Muto P. Radiosurgery and Stereotactic Radiotherapy for Brain Metastases According the New Prognostic Indexes: our Preliminary Experience Neurol Neurophysiol 2015, 6:6

7. AIOM-AIRTUM . Il numero del cancro in Italia 2019 . Intermedia Editore

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Retrospective Study: a. Incidence of metastatic disease at diagnosis	Incidence of metastatic disease at diagnosis	20 months (Interval from January 2019 to August 2020)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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