RB SFCE 2009 : Adjuvant treatment in extensive unilateral retinoblastoma primary enucleated

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Curie

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

18 Mar 2010 → ongoing

Decision date (initial)

2024-08-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514844-10-00

EudraCT number

2009-016448-38

ClinicalTrials.gov

NCT02870907

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

To determine DFS for unilateral retinoblastoma patients treated by primary enucleation followed by adjuvant treatment regarding histopathological risk factors

Secondary objectives 5

1. To determine long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.
2. To determine secondary bilateralisation frequency in patient with unilateral retinoblastoma
3. To determine the different histopathological risk factors frequency in unilateral retinoblastoma patient primary enucleated
4. To determine tumors genomic analysis in order to provide some new prognosis factors and better understading of tumorigenesis
5. To determine sensitivity of MRI in detecting extra ocular extension.

Conditions and MedDRA coding

Retinoblastoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male or female ≥2 months and <10 years of age at the time of signing the informed consent form;
2. Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation
3. No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor type.
4. Without medical cons-indication to study drugs.
5. Long term follow –up possible.
6. Written informed consent – a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines
7. Patients affiliated to a Social Security Regimen or beneficiary of the same
8. In case of post operative chemotherapy, patients must have adequate organ function: a- Adequate hematopoietic function Neutrophils>1.0x109/l, Platelets >100 x 109/l. b- Adequate hepatic function: grade II NCI CTC. c- Adequate renal function: serum creatinemia <1.5 x ULN for age with normal creatinine clearance estimated by SCHWARTZ formula. d- Audiometry < Grade II de Brock. e- Echocardiography normal in case of high dose cyclophophamide chemotherapy (3 g/m²).

Exclusion criteria 6

1. Bilateral and/or familial or trilateral retinoblastoma.
2. Unilateral retinoblastoma with indication of primary chemotherapy before enucleation: 1- One or several surgical risk factors : - Buphtalmia Exophtalmia. - Peri ocular inflamatory signs. 2- Extraocular extension : - Radiological retrolaminar extension (more than 3 mm behind the lamina cribosa) and or meningeal sheat optic nerve extension. - Extrascleral extension. - Lymp nodes extension.
3. Unilateral retinoblastoma with possibility of conservative treatment: - lesion(s) taking up less than 2/3 of the eyeball. - preservation of macula and papilla.
4. Metastatic extension at diagnosis
5. One inclusion criteria non observed.
6. Uncontrolled medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of extra ocular relapses

Secondary endpoints 5

1. Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation.
2. Number of patient with secondary bilateralisation
3. Evaluate the different histopathological risk factors frequency.
4. To determine tumors genomic.
5. Evaluate sensitivity of MRI in detecting extra ocular extension.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Curie

Sponsor organisation

Institut Curie

Address

26 Rue D Ulm

City

Paris

Postcode

75005

Country

France

Scientific contact point

Organisation

Institut Curie

Contact name

Isabelle AERTS

Public contact point

Organisation

Institut Curie

Contact name

Isabelle AERTS

Locations

1 EU/EEA country · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications