Evaluating the effects of radiotherapy in pediatric and adult patients with childhood cancers
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
This study looks at how radiation therapy affects both kids and adults who had childhood cancers, checking for any side effects and how well it works over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT06639165 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the short- and long-term toxicity and efficacy of radiotherapy in pediatric and adult patients who have undergone treatment for malignant neoplasms typical of childhood. The study will analyze data from patients treated at the Pediatric Radiotherapy Unit of the CRO in Aviano, focusing on those who received radiation therapy between 1991 and 2030. It will include both retrospective and prospective phases, with specific subgroup analyses based on age, pathology, and radiotherapy techniques, particularly Intensity-Modulated Radiation Therapy (IMRT).
Who should consider this trial
Good fit: Ideal candidates include pediatric, adolescent, and young adult patients under 25, as well as adult patients over 25 with specific childhood cancer histologies treated at the CRO in Aviano.
Not a fit: Patients with malignant neoplasms not typical of childhood or those who did not receive treatment at the Pediatric Radiotherapy Unit of the CRO in Aviano may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effects of radiotherapy, potentially improving treatment protocols and patient outcomes.
How similar studies have performed: While there is limited prospective data in this area, previous epidemiological studies have highlighted the importance of understanding long-term toxicity in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aviano, Pordenone
- Centro di Riferimento Oncologico — Aviano, Pordenone, Italy (Recruiting)
Study contacts
- Study coordinator: Maurizio Mascarin, MD
- Email: mascarin@cro.it
- Phone: 0434 659 536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.