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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860361
• Other study ID #: R1760722-IEO 1885
• Status: Recruiting
• Start date: April 14, 2023
• Est. completion date: October 1, 2030

Study information

• Verified date: June 2023
• Source: European Institute of Oncology
• Contact: Roberto Orecchia, Prof
• Phone: +39 0257489578
• Email: roberto.orecchia[@]ieo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 1, 2030
• Est. primary completion date: October 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• diagnosis of oncological disease (benign and malignant disease);

• candidates to proton therapy;

• able to provide informed consent.

Exclusion criteria:

• age < 18 years.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Efficacy: tumor response rate	tumor response rate according to RECIST criteria	10 years
Primary	Treatment Efficacy: % of tumor recurrence	% of tumor recurrence assessed by progression-free survival rate	10 years
Primary	Treatment Efficacy: rate of death	rate of death assessed by overall survival rates	10 years
Secondary	Treatment Toxicity: incidence of acute and late toxicity	incidence of acute and late toxicity collected according to CTCAE v. 6.0	10 years
Secondary	Treatment Toxicity: patients quality of life	patients quality of life assessed by internationally validated EORTC questionnaires	10 years
Secondary	Treatment Toxicity: patients pain	patients pain assessed by Visual Analog Score	10 years
Secondary	Treatment Toxicity: treatment costs	treatment costs assessed with quality adjusted life years (QALY)	10 years