Clinical trial NCT05860361: Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry
Official title: Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: proton therapy
registry
high-quality dataset
prospective data collection
hypofractionation
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged \>= 18 years with any type of oncologic disease (benign and malignant disease) eligible for proton therapy and able to provide informed consent (themselves, or through a designated legal guardian) to the registry.

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.

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.

Primary outcomes:
measure: Treatment Efficacy: tumor response rate
timeFrame: 10 years
measure: Treatment Efficacy: % of tumor recurrence
timeFrame: 10 years
measure: Treatment Efficacy: rate of death
timeFrame: 10 years
Secondary outcomes:
measure: Treatment Toxicity: incidence of acute and late toxicity
timeFrame: 10 years
measure: Treatment Toxicity: patients quality of life
timeFrame: 10 years
measure: Treatment Toxicity: patients pain
timeFrame: 10 years
measure: Treatment Toxicity: treatment costs
timeFrame: 10 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Roberto Orecchia
role: PRINCIPAL_INVESTIGATOR
References: