Total Body Irradiation Treatments for Patients Treated at European Institute of Oncology

Recruiting

• Conditions: Leukemia, Chronic; Lymphoma; Aplastic Anemia; Leukemia, Acute; Leukemia

• Registration Number: NCT06335277
• Lead Sponsor: European Institute of Oncology

Brief Summary

Patients eligible undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplant.

Detailed Description

Total Body Irradiation (TBI) is an oncological radiotherapy technique that has been used for several decades in patients undergoing bone marrow or peripheral stem cell transplantation.

The role of TBI is:

To suppress the recipient's immune system to prevent rejection of the donor's bone marrow, whether familial or non-familial.

To eradicate residual neoplastic cells following chemotherapy treatments.

TBI is typically employed in both neoplastic and non-neoplastic disorders affecting blood cell elements (e.g., acute and chronic leukemias, aplastic anemia, lymphomas, etc.), as well as other conditions such as neuroblastoma, Ewing's tumor, and pediatric sarcomas with a poor prognosis.

Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects. Data collection related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to total body irradiation treatments for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Study Timeline

• Study Start: 2018-02-22
• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplantation.
2. Signed informed consent

Exclusion Criteria

• Patients who do not undergo total body irradiation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years	Number of patients death
Disease free survival	5 years	Number of oncological event (local recurrence, distant metastasis, other primary tumor)

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy