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NCT Number: NCT06639165

Retrospective-perspective Observational Cohort Study on Toxicity and Efficacy of Radiotherapy in Pediatric and Adult Patients With Pediatric Histology Treated at the Pediatric Radiotherapy of the CRO in Aviano

Radiotherapy key role in pediatric oncology, despite the potential side effects especially in the long term, including the risk of radioinduced second cancers.

Very rarely malignant neoplasms typical of children and adolescents may present in adulthood, historically with a worse outcome, but for some of these histologies demonstrated recent results overlapping with those in pediatric age when treated with strategies similar to pediatric protocols and similar radiotherapy.

Long-term data on outcome and incidence of potential toxicity late radiation therapy in these populations almost exclusively from epidemiologic studies or retrospective case series. Prospective data are lacking, particularly in patients treated with IMRT and specifically with certain IMRT modalities such as Helical Tomotherapy, for which the CRO pediatric radiotherapy has documented experience. The main objective is to evaluate the short- and long-term toxicity secondary to radiotherapy performed at the Pediatric Radiotherapy of the CRO in Aviano, with specific subgroup analyses aimed at highlighting any differences mainly by age, pathology and radiotherapy technique.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location status: Recruiting

Location contact

Maurizio Mascarin, MD

CONTACT

[email protected]

0434 659 536 ext. +39

About this study

Radiotherapy key role in pediatric oncology, despite the potential side effects especially in the long term, including the risk of radioinduced second cancers.

Very rarely malignant neoplasms typical of children and adolescents may present in adulthood, historically with a worse outcome, but for some of these histologies demonstrated recent results overlapping with those in pediatric age when treated with strategies similar to pediatric protocols and similar radiotherapy.

Long-term data on outcome and incidence of potential toxicity late radiation therapy in these populations almost exclusively from epidemiologic studies or retrospective case series. Prospective data are lacking, particularly in patients treated with IMRT and specifically with certain IMRT modalities such as Helical Tomotherapy, for which the CRO pediatric radiotherapy has documented experience.

The main objective is to evaluate the short- and long-term toxicity secondary to radiotherapy performed at the Pediatric Radiotherapy of the CRO in Aviano, with specific subgroup analyses aimed at highlighting any differences mainly by age, pathology and radiotherapy technique.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric, adolescent, and young adult (<25 years old) patients with malignant neoplasm
  • Adult patients (≥25 years) with malignant neoplasm with histology typical of pediatric age but rarely also found in adults and typically treated wherever possible in pediatric protocols (mainly: Central nervous system malignancies such as medulloblastomas and other embryonal tumors, ependymomas, and germ cell tumors; soft tissue and bone sarcomas such as rhabdomyosarcomas and Ewing's sarcomas; nephroblastomas; neuroblastomas)
  • Underwent radiation treatment at the Pediatric Radiotherapy Unit of the CRO in Aviano
  • Between October 24, 1991, and September 30, 2020, with regard to the retrospective phase of the study, and between October 1, 2020, and September 30, 2030, with regard to the prospective phase of the study
  • And who provide informed consent to the study if alive and traceable at the time of enrollment with regard to the retrospective phase of the study and necessarily with regard to the prospective phase. Regarding deceased or alive but untraceable patients enrollable in the retrospective phase of the study, since these are patients who had already given consent to data processing at the time of the radiation therapy being analyzed and registration/enrollment in any specific treatment/research protocols, no new consent is required for the study

Exclusion criteria

  • Anything not covered in the inclusion criteria

Treatment and study plan

Primary outcomes

  1. Incidence of acute radiotherapy-related side effects

    Time frame: up to 10 years

    Cumulative incidence of acute side effects, with degree of individual toxicities encountered defined according to the most up-to-date version of the Common Terminology Criteria for Adverse Events (CTCAE) available at the time of analysis; analysis by subgroups of patients.

  2. Incidence of chronic side effects related to radiotherapy

    Time frame: up to 10 years

    Cumulative incidence of chronic side effects, with degree of the individual toxicities encountered defined according to the most up-to-date version of the CTCAE available at the time of analysis; analysis by subgroups of patients

  3. Incidence of second cancers

    Time frame: up to 10 years

    Cumulative incidence of second cancers; analysis by subgroups of patients.

Secondary outcomes

  1. Patient survival in terms of overall survival (OS, overall survival) and progression-free survival (PFS, progression-free survival)

    Time frame: up to 10 years

    Data will be summarized with survival curves according to Kaplan-Meier method; differences between selected subgroups of patients will be assessed by log-rank test. OS will be defined as time from beginning of the therapy until death from any cause or end of follow-up, whichever comes first.

  2. Adequacy of radiation treatment understood as compliance with the requirements in terms of target coverage

    Time frame: up to 10 years

    Frequency of patient with adequate target coverage

  3. Adequacy of radiation treatment understood as dose conformation to the target

    Time frame: up to 10 years

    Frequency of patient with adequate dose conformation to the target selection of alternative plans deemed superior and/or developed retrospectively with new radiotherapy techniques not yet available at the initial planning stage; qualitative-quantitative dosimetric comparisons between plans

  4. Homogeneity of dose to the target

    Time frame: up to 10 years

    Frequency of patient with homogeneity of dose to the target

Study contacts

Contact information is provided by the study sponsor or research team.

Maurizio Mascarin, MD

CONTACT

[email protected]

0434 659 536 ext. +39

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Acronym: RADIOPED

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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