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

NCT06639165 | Recruiting

• 1 other identifier: CRO-2020-65
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Toxicity

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 10 years

• 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

  up to 10 years

• Incidence of second cancers

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

  up to 10 years

Secondary Outcomes (4)

• 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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Maurizio Mascarin, MD

CONTACT

0434 659 536; mascarin@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2020
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

IT (1)