Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry

Study Overview
=================
Brief Summary
-----------------
The aim of the present registry is to prospectively collect data on patients treated with protontherapy in order to improve knowledge on indication, feasibility, and clinical results of hypofractionated schedules applied in the setting of patients.

Detailed Description
-----------------
Paucity and low evidence level data on protontherapy (PT) represent one of the main issues for the establishment of solid indications in the PT setting. Aim of the present registry is to provide a tool for systematic, prospective, harmonized, and multidimensional high-quality data collection to promote knowledge in the field of PT with a particular focus on the use of hypofractionation. All patients with any type of oncologic disease (benign and malignant disease) who will be eligible for PT at the European Institute of Oncology (IEO), will be included in the present registry. Three levels of data collection will be implemented: Level 1 clinical research (patients outcome and toxicity, quality of life, and cost/effectiveness analysis); Level 2 radiological research (radiomic and dosiomic analysis, as well as biological modeling); Level 3 Biological and Translational research (biological biomarkers and genomic data analysis). Endpoints and outcome measures of hypofractionation schedules will be evaluated in terms of either Treatment Efficacy (tumor response rate, time to progression/percentages of survivors/median survival, clinical, biological, and radiological biomarkers changes, identified as surrogate endpoints of cancer survival/response to treatment) and Toxicity. The study protocol has been approved by the IEO ethical committee (IEO 1885). Other than patients treated at IEO, additional PT facilities (equipped with IBA Proteus®ONE or Proteus®PLUS technologies) are planned to join the registry data collection. Moreover, the registry will be also fully integrated into international PT data collection networks.

Official Title
-----------------
Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: diagnosis of oncological disease (benign and malignant disease); candidates to proton therapy; able to provide informed consent. Exclusion criteria: - age < 18 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Efficacy | tumor response rate according to RECIST criteria | 10 years | 
| Treatment Efficacy | % of tumor recurrence assessed by progression-free survival rate | 10 years | 
| Treatment Efficacy | rate of death assessed by overall survival rates | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Toxicity | incidence of acute and late toxicity collected according to CTCAE v. 6.0 | 10 years | 
| Treatment Toxicity | patients quality of life assessed by internationally validated EORTC questionnaires | 10 years | 
| Treatment Toxicity | patients pain assessed by Visual Analog Score | 10 years | 
| Treatment Toxicity | treatment costs assessed with quality adjusted life years (QALY) | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proton therapy, registry, high-quality dataset, prospective data collection, hypofractionation