Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation Toxicity
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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.

Detailed description: 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: 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

Primary outcomes:
measure: Incidence of acute radiotherapy-related side effects
timeFrame: up to 10 years
measure: Incidence of chronic side effects related to radiotherapy
timeFrame: up to 10 years
measure: Incidence of second cancers
timeFrame: up to 10 years
Secondary outcomes:
measure: Patient survival in terms of overall survival (OS, overall survival) and progression-free survival (PFS, progression-free survival)
timeFrame: up to 10 years
measure: Adequacy of radiation treatment understood as compliance with the requirements in terms of target coverage
timeFrame: up to 10 years
measure: Adequacy of radiation treatment understood as dose conformation to the target
timeFrame: up to 10 years
measure: Homogeneity of dose to the target
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
state: Pordenone
Study officials:
References: