RANDOMIZED STUDY TO PROTECT FROM RADIATION IATROGENIC HYPOTHYROIDISM PATIENTS WITH MEDULLOBLASTOMA (ANY AGE, STAGE AND ANY BIOLOGICAL RISK) AND PEDIATRIC PATIENTS WITH HODGKIN LYMPHOMA AND NON-HODGKIN LYMPHOMA NEEDING RADIATION THERAPY ON THYROID SITE

RANDOMIZED STUDY TO PROTECT FROM RADIATION IATROGENIC HYPOTHYROIDISM PATIENTS WITH MEDULLOBLASTOMA (ANY AGE, STAGE AND ANY BIOLOGICAL RISK) AND PEDIATRIC PATIENTS WITH HODGKIN LYMPHOMA AND NON-HODGKIN LYMPHOMA NEEDING RADIATION THERAPY ON THYROID SITE - WIN-HYPO2021

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001385-38-IT

Enrollment

Registered

2021-08-30

Start date

2021-08-18

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

medulloblastoma, Hodgkin and non-Hodgkin lymphomas MedDRA version: 20.0 Level: PT Classification code 10027107 Term: Medulloblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 22.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10020206 Term: Hodgkin's d

Interventions

Product Name: Levotiroxina Product Code: [Levotiroxina] Pharmaceutical Form: Tablet INN or Proposed INN: LEVOTIROXINA CAS Number: 51-48-9 Current Sponsor code: Levotiroxina Other descriptive name: lev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma BEFORE RADIOTHERAPY (RT) PLANNING INCLUDING THYROID PARENCHYMA without previous primary or secondary hypothyroidism; 2. Written informed consent prior to any study-specific analysis and/or data collection. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 19 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma; 2. Not signed consent.

Design outcomes

Primary

Measure	Time frame
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).;Timepoint(s) of evaluation of this end point: 3 years from diagnosis	—

Measure

Time frame

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).;Timepoint(s) of evaluation of this end point: 3 years from diagnosis

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Countries

Italy

Contacts

Public ContactSC Pediatria

Fondazione IRCCS Istituto Nazionale dei Tumori

luna.boschetti@istitutotumori.mi.it0223902648

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026