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Longitudinal Registry Including Patients Treated With Heavy Particles

ConditionsCancerOncologyRadiation ExposureRadiotherapy Side EffectRadiation ToxicityRare Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCNAO National Center of Oncological Hadrontherapy

About this trial

The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia.

By keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients treated with heavy particles at Fondazione CNAO, Pavia

Patients who have the ability to understand and be willing to sign a written informed consent document

Disqualifiers

Patients or legal guardians who are unable to understand informed consent document

Trial population

All patients treated with particle therapy, protons and/or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO), based in Pavia, who have signed the written informed consent document, can be enrolled in the study

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Heavy-ion therapy (hadrontherapy)

    Radiation

    Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.

Treatment groups

3,000 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Brain tumors, skull base tumors, spinal cord tumors1 intervention
Group B: Ocular melanomas1 intervention
Group C: Head and Neck tumors1 intervention
Group D: Tumors of thorax and/or abdomen1 intervention
Group E: Pelvic tumors1 intervention
Group F: Sarcomas and tumors of limbs1 intervention
Group G: Pediatric tumors1 intervention
Group H: Mobile spine and sacral tumors1 intervention

Trial outcomes

Primary outcomes

1

Real world data collection

To collect real world data of patients treated with radiotherapy, to support particle radiotherapy and to provide evidence of the role of radiation oncology within the multidisciplinary approach.

Time frame
50 years

Secondary outcomes

1

Disease evolution

To analyze the disease course and treatment performed by collecting demographic, disease characteristics and delivered treatment

Time frame
50 years
2

Predicitive models

To collect details about the radiation treatment and radiobiological parameters to develop predictive models (outcome and toxicity)

Time frame
50 years
3

Outcome data

To collect outcome data (in terms of overall survival, progression free-survival and local control) and to correlate them with the delivered treatment

Time frame
50 years
4

Toxicities

To define acute, intermediate and late toxicities, according to CTCAE v 5.0 and to correlate it with the delivered treatment

Time frame
50 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CNAO National Center of Oncological Hadrontherapy

Lead sponsor

Source ClinicalTrials.gov
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