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

Recruiting

• Conditions: Cancer

• Registration Number: NCT05860361
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Study First Submitted: 2023-04-07
• Study Start: 2023-04-14
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Status Verified: 2023-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2028-10-01
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy: % of tumor recurrence	10 years	% of tumor recurrence assessed by progression-free survival rate
Treatment Efficacy: tumor response rate	10 years	tumor response rate according to RECIST criteria
Treatment Efficacy: rate of death	10 years	rate of death assessed by overall survival rates

Secondary Outcome Measures

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

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy