Randomized study to protect from radiation iatrogenic hypothyroidism patients with medulloblastoma (any stage, any biological risk) and pediatric patients with Hodgkin lymphoma and non-Hodgkin lymphoma needing radiation therapy on thyroid site - WINHYPO 2021

Phase 1

Recruiting

Conditions: Hodgkin and non Hodgkin lymphoma, Medulloblastoma
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-512642-42-00

Lead Sponsor: Fondazione IRCCS Istituto Nazionale Dei Tumori

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 65

Inclusion Criteria

Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma BEFORE RADIOTHERAPY (RT) PLANNING INCLUDING THYROID PARENCHYMA without previous primary or secondary hypothyroidism;, Written informed consent prior to any study-specific analysis and/or data collection.

Exclusion Criteria

Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;, Not signed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchima on the intention-to-treat population will be the main end-point. For both treatment groups (radiotherapy / radiotherapy + Levo-thyroxin), the analysis set will consist of patients evaluated with TSH blood dosage to evaluate the onset of hypothyroidism within three years from the radiotherapy beginning.;Main Objective: To evaluate if the incidence of hypothyroidism after radiation therapy in medulloblastoma, Hodgkin and non-Hodgkin lymphomas can be reduced by TSH suppression during irradiation.;Secondary Objective: Secondary objective will be the number and the type of parenchyma alterations after irradiation in all patients (both groups).

Secondary Outcome Measures