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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335277
• Other study ID #: IEO 0727
• Status: Recruiting
• Start date: February 22, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Barbara Alicja Jereczek
• Phone: +39 02 57489326
• Email: barbara.jereczek[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Aplastic
• Aplastic Anemia
• Leukemia
• Leukemia, Acute
• Lymphoma

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Number of patients death	5 years
Primary	Disease free survival	Number of oncological event (local recurrence, distant metastasis, other primary tumor)	5 years