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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512642-42-00
Enrollment
65
Registered
2024-05-24
Start date
2021-12-13
Completion date
Unknown
Last updated
2024-05-24

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

Conditions

Hodgkin and non Hodgkin lymphoma, Medulloblastoma

Brief summary

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.

Interventions

DRUGLevotiroxina Teva 25 microgrammi compresse

Sponsors

Fondazione IRCCS Istituto Nazionale Dei Tumori
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026