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

March 27, 2024 updated by: European Institute of Oncology
Patients eligible undergoing total body irradiation as candidates for bone marrow or peripheral stem cell transplant.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • European Institute of Oncology
        • Contact:
          • Barbara Alicja Jereczek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated at European Institute of Oncology with Total Body Irradiation (TBI)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Total Body Irradiation (TBI)
Patients treated at European Institute of Oncology with Total Body Irradiation (TBI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 5 years
Number of oncological event (local recurrence, distant metastasis, other primary tumor)
5 years
Overall Survival
Time Frame: 5 years
Number of patients death
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Barbara Alicja Jereczek, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 0727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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