Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)
RB SFCE 09
1 other identifier
interventional
195
1 country
27
Brief Summary
Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2010
CompletedFirst Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
January 7, 2026
January 1, 2026
21 years
August 9, 2016
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of extra ocular relapses
5 years
Secondary Outcomes (5)
Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.
5 years
Number of patient with secondary bilateralisation
5 years
Evaluate the different histopathological risk factors frequency
5 years
To determine tumors genomic
at the inclusion
Evaluate sensitivity of MRI in detecting extra ocular extension
At the inclusion
Study Arms (4)
Low risk group
EXPERIMENTALNo treatment
Intermediate risk sub group 1
EXPERIMENTAL2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
Intermediate risk sub group 2
EXPERIMENTAL2 courses of Vincristin and Carboplatin
High risk group
EXPERIMENTAL* Orbital irradiation * 3 cycles of two different types of alternating chemotherapy courses (id 6 courses) : * Etoposide (100 mg/m²/d) and Carboplatin (160 mg/m²/d) with intrathecal Thiotepa injection. * Vincristin (1,5 mg/m²/d) - Cyclophosphamide (1000 mg/m²/d) * Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamide. * High dose chemotherapy : * Carboplatin (AUC : 7/d) - etoposide (250 mg/m²/d) - Thiotepa (300 mg/m²/d) * Peripheral bood stem cell transplantation.
Interventions
100 mg/m²/d, IV (in the vein) from D1 to D5.
1, 5 mg/m²/d, IV at D1.
45 Grays (Standard or external beam radiotherapy).
160 mg/m²/d, IV from D1 to D5.
300 mg/m²/d, IV from D22 to D26.
15 mg, intrathecal Thiotepa injection at D1.
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.
at D0
Eligibility Criteria
You may qualify if:
- Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines;
- Male or female ≥2 months and \<10 years of age at the time of signing the informed consent form;
- Diagnosis of non familial extensive unilateral retinoblastoma treated by primary enucleation
- 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).
- Patients affiliated to a Social Security Regimen or beneficiary of the same
- No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types
- Without medical cons-indication to study drugs.
You may not qualify if:
- 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:
- Metastatic extension at diagnosis
- Uncontrolled medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (27)
Chr Felix Guyon
Saint-Denis, La Réunion, 97405, France
Hopital Nord Chu Amiens
Amiens, 80054, France
Chu Angers
Angers, 49033, France
Hopital Jean Minioz
Besançon, 25030, France
Chu R; Pellegrin
Bordeaux, 33076, France
Chu Morvan
Brest, 29609, France
CHU CAEN
Caen, 14033, France
Chu Estaing
Clermont-Ferrand, 63003, France
Chu Bocage
Dijon, 21079, France
Chu de Grenoble
Grenoble, 38043, France
Centre Oscar Lambret
Lille, 59020, France
Chu Limoges
Limoges, 87042, France
Centre Leon Berard
Lyon, 69373, France
Hopital D'Enfants La Timone
Marseille, 13385, France
Hopital Arnaud de Villeneuve
Montpellier, 34295, France
Chu Nantes
Nantes, 44093, France
Chu de Nice
Nice, 06202, France
Institut Curie
Paris, 75005, France
Chu de Poitiers
Poitiers, 86021, France
Chur de Reims
Reims, 51100, France
Chu de Rennes
Rennes, 35056, France
Chu de Rouen
Rouen, 76031, France
Chu Saint Etienne
Saint-Etienne, 420555, France
Hoptial Hautepierre
Strasbourg, 67098, France
Chu Toulouse
Toulouse, 31026, France
Chu Tours
Tours, 37044, France
Chu Nancy
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2016
First Posted
August 17, 2016
Study Start
March 18, 2010
Primary Completion (Estimated)
March 1, 2031
Study Completion (Estimated)
March 1, 2031
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
- Access Criteria
- Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.