CancerNCT05860361
Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry
An observational study of Cancer, run by European Institute of Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2023to 1 Oct 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- diagnosis of oncological disease (benign and malignant disease);
- candidates to proton therapy;
- able to provide informed consent.
Who cannot join
- age < 18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Daniela Alterio
About this study
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.
Read the 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.
- Conditions
- Cancer
- Keywords
- proton therapy, registry, high-quality dataset, prospective data collection, hypofractionation
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy: tumor response rate
tumor response rate according to RECIST criteria
Measured: 10 years
Treatment Efficacy: % of tumor recurrence
% of tumor recurrence assessed by progression-free survival rate
Measured: 10 years
Treatment Efficacy: rate of death
rate of death assessed by overall survival rates
Measured: 10 years
Secondary outcomes (4)
Treatment Toxicity: incidence of acute and late toxicity
incidence of acute and late toxicity collected according to CTCAE v. 6.0
Measured: 10 years
Treatment Toxicity: patients quality of life
patients quality of life assessed by internationally validated EORTC questionnaires
Measured: 10 years
Treatment Toxicity: patients pain
patients pain assessed by Visual Analog Score
Measured: 10 years
Treatment Toxicity: treatment costs
treatment costs assessed with quality adjusted life years (QALY)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start14 Apr 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Orecchia, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860361
- Sponsor's protocol ID
- R1760722-IEO 1885
- Status last verified
- Jun 2023
- First submitted
- 7 Apr 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry
- ClinicalTrials.gov ID
- NCT05860361
- Acronym / sponsor ID
- R1760722-IEO 1885
- Conditions
- Cancer
- Keywords
- proton therapy, registry, high-quality dataset, prospective data collection, hypofractionation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- diagnosis of oncological disease (benign and malignant disease);
- candidates to proton therapy;
- able to provide informed consent.
Key exclusion criteria (1 listed)
- age < 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Efficacy: tumor response rate
Time frame: 10 years
tumor response rate according to RECIST criteria
Treatment Efficacy: % of tumor recurrence
Time frame: 10 years
% of tumor recurrence assessed by progression-free survival rate
Treatment Efficacy: rate of death
Time frame: 10 years
rate of death assessed by overall survival rates
4 secondary outcomes
Treatment Toxicity: incidence of acute and late toxicity
Time frame: 10 years
Treatment Toxicity: patients quality of life
Time frame: 10 years
Treatment Toxicity: patients pain
Time frame: 10 years
Treatment Toxicity: treatment costs
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Orecchia principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Orecchia, Prof (+39 0257489578, roberto.orecchia@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy: tumor response rate (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.