Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639165
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief 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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADIOPED
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None