Radiation Toxicity
Conditions
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.
Interventions
None listed
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of second cancers | up to 10 years | Cumulative incidence of second cancers; analysis by subgroups of patients. |
| Incidence of acute radiotherapy-related side effects | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient survival in terms of overall survival (OS, overall survival) and progression-free survival (PFS, progression-free survival) | 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. |
| Homogeneity of dose to the target | up to 10 years | Frequency of patient with homogeneity of dose to the target |
| Adequacy of radiation treatment understood as compliance with the requirements in terms of target coverage | up to 10 years | Frequency of patient with adequate target coverage |
| Adequacy of radiation treatment understood as dose conformation to the target | 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 |
Countries
Italy
Contacts
Primary ContactMaurizio Mascarin, MD
Outcome results
None listed