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Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009) | Clinical Trials | Clareo Health

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Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

NCT02870907•Institut Curie

View on ClinicalTrials.gov

Summary

Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

Detailed Description

Post operative chemotherapy +/- radiotherapy according to histopathological risk factors of the International Retinoblastoma Staging Working Group. * Low risk group : * No optic nerve involvement. * Intra and prelaminar involvement * No choroidal involvement. * Minimal superficial choroidal involvement . * Intermediate risk group, 2 sub groups : * Sub group 1 : * Retrolaminar involvement without Invasion of surgical margin associated or not to massive choroidal involvement * Anterior segment involvement. * Intrascleral involvement. * Sub Group 2 : * Isolated massive choroidal involvement. * High risk group : * Invasion of the surgical margin of the optic nerve * and/or microscopic extrascleral involvement * Optic nerve meningeal sheat involvement .

Eligibility

Age

0 - 10 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines;
•2. Male or female ≥2 months and \<10 years of age at the time of signing the informed consent form;
•3. Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation
•4. In case of post operative chemotherapy, patients must have adequate organ function:
•* Adequate hematopoietic function Neutrophils\>1.0x109/l, Platelets \>100 x 109/l.
•* Adequate hepatic function: grade II NCI CTC
•* Adequate renal function: serum creatinemia \<1.5 x ULN for age with normal creatinine clearance estimated by SCHWARTZ formula
•* Audiometry \< Grade II de Brock.
•* Echocardiography normal in case of high dose cyclophosphamide chemotherapy (3 g/m²).
•5. Patients affiliated to a Social Security Regimen or beneficiary of the same
+3 more criteria

Exclusion Criteria

•Bilateral and/or familial or trilateral retinoblastoma.
•Unilateral retinoblastoma with indication of primary chemotherapy before enucleation:
•* One or several surgical risk factors
•* Buphthalmia Exophthalmia.
•* Peri ocular inflammatory signs.
•* Extraocular extension :
•* Radiological retrolaminar extension (more than 3 mm behind the lamina cribrosa) and or meningeal sheat optic nerve extension.
•* Extrascleral extension
•* Lymp nodes extension
•Unilateral retinoblastoma with possibility of conservative treatment:
+1 more criteria

Locations (27)

Chr Felix Guyon

Saint-Denis, La Réunion, France

Hopital Nord Chu Amiens

Amiens, France

Chu Angers

Angers, France

Hopital Jean Minioz

Besançon, France

Chu R; Pellegrin

Bordeaux, France

Chu Morvan

Brest, France

CHU CAEN

Caen, France

Chu Estaing

Clermont-Ferrand, France

Chu Bocage

Dijon, France

Chu de Grenoble

Grenoble, France

Key Dates

Start Date

March 18, 2010

Primary Completion Date

March 1, 2031

Completion Date

March 1, 2031

Last Updated

January 7, 2026

Enrollment

195

ESTIMATED participants

Conditions

Retinoblastoma

Interventions

Observation

OTHER

Etoposide

DRUG

Vincristine

DRUG

Orbital irradiation

RADIATION

Carboplatin

DRUG

Vincristine

DRUG

Cyclophosphamide

DRUG

Carboplatin

DRUG

Etoposide

DRUG

Carboplatin

DRUG

Thiotepa

DRUG

Vincristine

DRUG

Cyclophosphamide

DRUG

Cytapheresis

PROCEDURE

Carboplatin

DRUG

Etoposide

DRUG

Thiotepa

DRUG

Peripheral bood stem cell transplantation

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)

Inclusion Criteria

Exclusion Criteria

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