Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009) (RB SFCE 09)

January 5, 2026 updated by: Institut Curie

Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France, 80054
        • Hopital Nord Chu Amiens
      • Angers, France, 49033
        • CHU Angers
      • Besançon, France, 25030
        • Hopital Jean Minioz
      • Bordeaux, France, 33076
        • Chu R; Pellegrin
      • Brest, France, 29609
        • CHU Morvan
      • Caen, France, 14033
        • CHU Caen
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • Dijon, France, 21079
        • CHU Bocage
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Limoges, France, 87042
        • CHU Limoges
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13385
        • Hopital d'Enfants la Timone
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve
      • Nantes, France, 44093
        • CHU Nantes
      • Nice, France, 06202
        • CHU de Nice
      • Paris, France, 75005
        • Institut Curie
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Reims, France, 51100
        • Chur de Reims
      • Rennes, France, 35056
        • CHU de Rennes
      • Rouen, France, 76031
        • CHU de Rouen
      • Saint-Etienne, France, 420555
        • CHU Saint Etienne
      • Strasbourg, France, 67098
        • Hoptial Hautepierre
      • Toulouse, France, 31026
        • CHU Toulouse
      • Tours, France, 37044
        • CHU Tours
      • Vandœuvre-lès-Nancy, France, 54500
        • CHU Nancy
    • La Réunion
      • Saint-Denis, La Réunion, France, 97405
        • Chr Felix Guyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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
  6. No chemotherapy or radiotherapy prior to administration of the first dose of study treatment for retinoblastoma or other tumor types
  7. Without medical cons-indication to study drugs.

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:
  • Metastatic extension at diagnosis
  • One inclusion criteria non observed
  • Uncontrolled medical conditions, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intermediate risk sub group 1
2 cycles (4 courses): 2 courses of etoposide and Carboplatin from D1 to D5 and Vincristin at D22 and D26- Cyclophosphamide from D22 to D26.
Drug: Etoposide
100 mg/m²/d, IV (in the vein) from D1 to D5.
Other Names:
  • Intermediate risk sub group 1
Drug: Vincristine
1, 5 mg/m²/d, IV at D1.
Other Names:
  • Intermediate risk sub group 2
Drug: Carboplatin
160 mg/m²/d, IV from D1 to D5.
Other Names:
  • Intermediate risk sub group 1
Drug: Vincristine
1,5 mg/m²/d, IV at D22 and D26
Other Names:
  • Intermediate risk sub group 1
Drug: Cyclophosphamide
300 mg/m²/d, IV from D22 to D26.
Other Names:
  • Intermediate risk sub group 1
Drug: Carboplatin
560 mg/m²/d, IV at D1.
Other Names:
  • Intermediate risk sub group 2
Drug: Etoposide
100 mg/m²/d, IV from D1 to D5
Other Names:
  • High risk group
Drug: Carboplatin
160 mg/m²/d,IV from D1 to D5
Other Names:
  • High risk group
Drug: Vincristine
1,5 mg/m²/d), IV at D22
Other Names:
  • High risk group
Drug: Cyclophosphamide
1000 mg/m²/d, IV from D22 à D24.
Other Names:
  • High risk group
Drug: Carboplatin
AUC : 7/d, IV from D-8 to D-6.
Other Names:
  • High risk group
Drug: Etoposide
250 mg/m²/d, IV from D -5 to D-3.
Other Names:
  • High risk group
Experimental: Intermediate risk sub group 2
2 courses of Vincristin and Carboplatin
Drug: Vincristine
1, 5 mg/m²/d, IV at D1.
Other Names:
  • Intermediate risk sub group 2
Drug: Carboplatin
160 mg/m²/d, IV from D1 to D5.
Other Names:
  • Intermediate risk sub group 1
Drug: Vincristine
1,5 mg/m²/d, IV at D22 and D26
Other Names:
  • Intermediate risk sub group 1
Drug: Carboplatin
560 mg/m²/d, IV at D1.
Other Names:
  • Intermediate risk sub group 2
Drug: Carboplatin
160 mg/m²/d,IV from D1 to D5
Other Names:
  • High risk group
Drug: Vincristine
1,5 mg/m²/d), IV at D22
Other Names:
  • High risk group
Drug: Carboplatin
AUC : 7/d, IV from D-8 to D-6.
Other Names:
  • High risk group
Experimental: High risk group
  • 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.
Drug: Etoposide
100 mg/m²/d, IV (in the vein) from D1 to D5.
Other Names:
  • Intermediate risk sub group 1
Drug: Vincristine
1, 5 mg/m²/d, IV at D1.
Other Names:
  • Intermediate risk sub group 2
Drug: Carboplatin
160 mg/m²/d, IV from D1 to D5.
Other Names:
  • Intermediate risk sub group 1
Drug: Vincristine
1,5 mg/m²/d, IV at D22 and D26
Other Names:
  • Intermediate risk sub group 1
Drug: Cyclophosphamide
300 mg/m²/d, IV from D22 to D26.
Other Names:
  • Intermediate risk sub group 1
Drug: Carboplatin
560 mg/m²/d, IV at D1.
Other Names:
  • Intermediate risk sub group 2
Drug: Etoposide
100 mg/m²/d, IV from D1 to D5
Other Names:
  • High risk group
Drug: Carboplatin
160 mg/m²/d,IV from D1 to D5
Other Names:
  • High risk group
Drug: Vincristine
1,5 mg/m²/d), IV at D22
Other Names:
  • High risk group
Drug: Cyclophosphamide
1000 mg/m²/d, IV from D22 à D24.
Other Names:
  • High risk group
Drug: Carboplatin
AUC : 7/d, IV from D-8 to D-6.
Other Names:
  • High risk group
Drug: Etoposide
250 mg/m²/d, IV from D -5 to D-3.
Other Names:
  • High risk group
Radiation: Orbital irradiation
45 Grays (Standard or external beam radiotherapy).
Other Names:
  • High risk group
Drug: Thiotepa
15 mg, intrathecal Thiotepa injection at D1.
Other Names:
  • High risk group
Procedure: Cytapheresis
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.
Other Names:
  • High risk group
Drug: Thiotepa
300 mg/m²/d, IV from D-5 to D-3.
Other Names:
  • High risk group
Procedure: Peripheral bood stem cell transplantation
at D0
Other Names:
  • High risk group
Experimental: Low risk group
No treatment
Other: Observation
no post operative chemotherapy
Other Names:
  • Low risk group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of extra ocular relapses
Time Frame: 5 years
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.
Time Frame: 5 years
Number of participants with treatment-related Adverse Events as assessed by CTCAE v3.0.
5 years
Number of patient with secondary bilateralisation
Time Frame: 5 years
5 years
Evaluate the different histopathological risk factors frequency
Time Frame: 5 years
Number of patient in each histopathological risk group
5 years
To determine tumors genomic
Time Frame: at the inclusion
Tumor genomic characterization in order to provide some new prognosis factors and better understanding of tumorigenesis by using of NGS (Next Generation Sequencing) techniques
at the inclusion
Evaluate sensitivity of MRI in detecting extra ocular extension
Time Frame: At the inclusion
Number of extra ocular extension detected by MRI
At the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2010

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IC 2009-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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