Overview
Sponsor-declared trial summary
Hodgkin and non Hodgkin lymphoma
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.
Key facts
- Sponsor
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Dec 2021 → ongoing
- Decision date (initial)
- 2024-05-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512642-42-00
- EudraCT number
- 2021-001385-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Prophylaxis
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 objectives 1
- Secondary objective will be the number and the type of parenchyma alterations after irradiation in all patients (both groups).
Conditions and MedDRA coding
Hodgkin and non Hodgkin lymphoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 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 2
- Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;
- Not signed consent.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Levotiroxina Teva 25 microgrammi compresse
PRD1172325 · Product
- Active substance
- Levothyroxine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 µg/Kg microgram(s)/kilogram
- Max total dose
- 2 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- H03AA01 — LEVOTHYROXINE SODIUM
- Marketing authorisation
- 040619049
- MA holder
- TEVA ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione IRCCS Istituto Nazionale Dei Tumori
- Sponsor organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Address
- Via Giacomo Venezian 1
- City
- Milan
- Postcode
- 20133
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact name
- Maura Massimino
Public contact point
- Organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact name
- Maura Massimino
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 65 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2021-12-13 | 2021-12-13 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-18 | Italy | No conclusion 2024-05-13
|
2024-05-24 |