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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiation Toxicity
- Sponsor
- Centro di Riferimento Oncologico - Aviano
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Incidence of acute radiotherapy-related side effects
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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
Incidence of second cancers
Time Frame: up to 10 years
Cumulative incidence of second cancers; analysis by subgroups of patients.
Secondary Outcomes
- Patient survival in terms of overall survival (OS, overall survival) and progression-free survival (PFS, progression-free survival)(up to 10 years)
- Adequacy of radiation treatment understood as compliance with the requirements in terms of target coverage(up to 10 years)
- Adequacy of radiation treatment understood as dose conformation to the target(up to 10 years)
- Homogeneity of dose to the target(up to 10 years)