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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentro di Riferimento Oncologico - Aviano

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

All pediatric, adolescent and young adult (\<25 years old) patients with malignant neoplasm e All adult patients (≥25 years) with malignant neoplasm with histology typical of pediatric age but also rarely found in adults and typically treated wherever possible in pediatric protocols (mainly: malignant tumors affecting the central nervous system such as medulloblastomas and other embryonal tumors, ependymomas, and tumors with germ cells; soft tissue and bone sarcomas such as rhabdomyosarcomas and Ewing's sarcomas; nephroblastomas; neuroblastomas) undergoing radiation treatment at the pediatric radiation therapy of the CRO of Aviano

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Incidence of acute radiotherapy-related side effects

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.

Time frame
up to 10 years
2

Incidence of chronic side effects related to radiotherapy

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

Time frame
up to 10 years
3

Incidence of second cancers

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

Time frame
up to 10 years

Secondary outcomes

1

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

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.

Time frame
up to 10 years
2

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

Frequency of patient with adequate target coverage

Time frame
up to 10 years
3

Adequacy of radiation treatment understood as dose conformation to the target

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

Time frame
up to 10 years
4

Homogeneity of dose to the target

Frequency of patient with homogeneity of dose to the target

Time frame
up to 10 years

Other outcomes

Sponsors and contacts

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