RetinoblastomaPhase 2RB SFCE 09NCT02870907
Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)
A Phase 2 study testing Observation, Etoposide and Vincristine in people with Retinoblastoma, run by Institut Curie at 27 sites in France.
Trial summary
Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group. Read more about this study
- Who is it for?
- Ages 2 months to 10 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Observation, Etoposide and Vincristine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 27 sitesFrance
- Study dates
- 18 Mar 2010to 1 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 :
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- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Hopital Nord Chu Amiens
Amiens, 80054
Chu Angers
Angers, 49033
Hopital Jean Minioz
Besançon, 25030
Chu R; Pellegrin
Bordeaux, 33076
Chu Morvan
Brest, 29609
CHU CAEN
Caen, 14033
Chu Estaing
Clermont-Ferrand, 63003
Chu Bocage
Dijon, 21079
Chu de Grenoble
Grenoble, 38043
Centre Oscar Lambret
Lille, 59020
Chu Limoges
Limoges, 87042
Centre Leon Berard
Lyon, 69373
Hopital D'Enfants La Timone
Marseille, 13385
Hopital Arnaud de Villeneuve
Montpellier, 34295
Chu Nantes
Nantes, 44093
Chu de Nice
Nice, 06202
Institut Curie
Paris, 75005
Chu de Poitiers
Poitiers, 86021
Chur de Reims
Reims, 51100
Chu de Rennes
Rennes, 35056
Chu de Rouen
Rouen, 76031
Chr Felix Guyon
Saint-Denis, La Réunion, 97405
Chu Saint Etienne
Saint-Etienne, 420555
Hoptial Hautepierre
Strasbourg, 67098
Chu Toulouse
Toulouse, 31026
Chu Tours
Tours, 37044
Chu Nancy
Vandœuvre-lès-Nancy, 54500
About this study
Official title: 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.
Read the 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 .
- Conditions
- Retinoblastoma
- Being tested
- Observation, Etoposide, Vincristine, Orbital irradiation, Carboplatin
- Keywords
- primary enucleation, retinoblastoma
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Also called Low risk group
no post operative chemotherapy
EtoposideDrug
Also called Intermediate risk sub group 1
100 mg/m²/d, IV (in the vein) from D1 to D5.
VincristineDrug
Also called Intermediate risk sub group 2
1, 5 mg/m²/d, IV at D1.
Orbital irradiationRadiation
Also called High risk group
45 Grays (Standard or external beam radiotherapy).
CarboplatinDrug
Also called Intermediate risk sub group 1
160 mg/m²/d, IV from D1 to D5.
VincristineDrug
Also called Intermediate risk sub group 1
1,5 mg/m²/d, IV at D22 and D26
CyclophosphamideDrug
Also called Intermediate risk sub group 1
300 mg/m²/d, IV from D22 to D26.
CarboplatinDrug
Also called Intermediate risk sub group 2
560 mg/m²/d, IV at D1.
EtoposideDrug
Also called High risk group
100 mg/m²/d, IV from D1 to D5
CarboplatinDrug
Also called High risk group
160 mg/m²/d,IV from D1 to D5
ThiotepaDrug
Also called High risk group
15 mg, intrathecal Thiotepa injection at D1.
VincristineDrug
Also called High risk group
1,5 mg/m²/d), IV at D22
CyclophosphamideDrug
Also called High risk group
1000 mg/m²/d, IV from D22 à D24.
CytapheresisProcedure or surgery
Also called High risk group
Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.
CarboplatinDrug
Also called High risk group
AUC : 7/d, IV from D-8 to D-6.
EtoposideDrug
Also called High risk group
250 mg/m²/d, IV from D -5 to D-3.
ThiotepaDrug
Also called High risk group
300 mg/m²/d, IV from D-5 to D-3.
Peripheral bood stem cell transplantationProcedure or surgery
Also called High risk group
at D0
| Study group | Role | What they receive |
|---|---|---|
| Low risk group | Experimental | No treatment Receives: Other: Observation |
| Intermediate risk sub group 1 | Experimental | 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. Receives: Drug: Etoposide; Drug: Carboplatin; Drug: Vincristine; Drug: Cyclophosphamide |
| Intermediate risk sub group 2 | Experimental | 2 courses of Vincristin and Carboplatin Receives: Drug: Vincristine; Drug: 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. Receives: Radiation: Orbital irradiation; Drug: Etoposide; Drug: Carboplatin; Drug: Thiotepa; Drug: Vincristine; Drug: Cyclophosphamide; Procedure: Cytapheresis; Procedure: Peripheral bood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of extra ocular relapses
Measured: 5 years
Secondary outcomes (5)
Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.
Number of participants with treatment-related Adverse Events as assessed by CTCAE v3.0.
Measured: 5 years
Number of patient with secondary bilateralisation
Measured: 5 years
Evaluate the different histopathological risk factors frequency
Number of patient in each histopathological risk group
Measured: 5 years
To determine tumors genomic
Tumor genomic characterization in order to provide some new prognosis factors and better understanding of tumorigenesis by using of NGS (Next Generation Sequencing) techniques
Measured: at the inclusion
Evaluate sensitivity of MRI in detecting extra ocular extension
Number of extra ocular extension detected by MRI
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start18 Mar 2010
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870907
- Sponsor's protocol ID
- IC 2009-04
- Acronym
- RB SFCE 09
- Status last verified
- Jan 2026
- First submitted
- 9 Aug 2016
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated
- ClinicalTrials.gov ID
- NCT02870907
- Acronym / sponsor ID
- RB SFCE 09 / IC 2009-04
- Conditions
- Retinoblastoma
- Keywords
- primary enucleation, retinoblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 18 Mar 2010 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low risk group | Experimental | Other: ObservationNo treatment |
| Intermediate risk sub group 1 | Experimental | Drug: Etoposide, Drug: Carboplatin, Drug: Vincristine, Drug: Cyclophosphamide2 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 | Experimental | Drug: Vincristine, Drug: Carboplatin2 courses of Vincristin and Carboplatin |
| High risk group | Experimental | Radiation: Orbital irradiation, Drug: Etoposide, Drug: Carboplatin, Drug: Thiotepa, Drug: Vincristine, Drug: Cyclophosphamide, Procedure: Cytapheresis, Procedure: Peripheral bood stem cell transplantation* 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. |
Who may qualify
- Ages
- 2 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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:
- Patients affiliated to a Social Security Regimen or beneficiary of the same
Key exclusion criteria (13 listed)
- Bilateral and/or familial or trilateral retinoblastoma.
- Unilateral retinoblastoma with indication of primary chemotherapy before enucleation:
- Unilateral retinoblastoma with possibility of conservative treatment:
- Metastatic extension at diagnosis
- One inclusion criteria non observed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationAlso: Low risk groupno post operative chemotherapy | Other | Low risk group |
| EtoposideAlso: Intermediate risk sub group 1100 mg/m²/d, IV (in the vein) from D1 to D5. | Drug | Intermediate risk sub group 1 |
| VincristineAlso: Intermediate risk sub group 21, 5 mg/m²/d, IV at D1. | Drug | Intermediate risk sub group 2 |
| Orbital irradiationAlso: High risk group45 Grays (Standard or external beam radiotherapy). | Radiation | High risk group |
| CarboplatinAlso: Intermediate risk sub group 1160 mg/m²/d, IV from D1 to D5. | Drug | Intermediate risk sub group 1 |
| VincristineAlso: Intermediate risk sub group 11,5 mg/m²/d, IV at D22 and D26 | Drug | Intermediate risk sub group 1 |
| CyclophosphamideAlso: Intermediate risk sub group 1300 mg/m²/d, IV from D22 to D26. | Drug | Intermediate risk sub group 1 |
| CarboplatinAlso: Intermediate risk sub group 2560 mg/m²/d, IV at D1. | Drug | Intermediate risk sub group 2 |
| EtoposideAlso: High risk group100 mg/m²/d, IV from D1 to D5 | Drug | High risk group |
| CarboplatinAlso: High risk group160 mg/m²/d,IV from D1 to D5 | Drug | High risk group |
| ThiotepaAlso: High risk group15 mg, intrathecal Thiotepa injection at D1. | Drug | High risk group |
| VincristineAlso: High risk group1,5 mg/m²/d), IV at D22 | Drug | High risk group |
| CyclophosphamideAlso: High risk group1000 mg/m²/d, IV from D22 à D24. | Drug | High risk group |
| CytapheresisAlso: High risk groupCytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid. | Procedure or surgery | High risk group |
| CarboplatinAlso: High risk groupAUC : 7/d, IV from D-8 to D-6. | Drug | High risk group |
| EtoposideAlso: High risk group250 mg/m²/d, IV from D -5 to D-3. | Drug | High risk group |
| ThiotepaAlso: High risk group300 mg/m²/d, IV from D-5 to D-3. | Drug | High risk group |
| Peripheral bood stem cell transplantationAlso: High risk groupat D0 | Procedure or surgery | High risk group |
Primary outcome
Rate of extra ocular relapses
Time frame: 5 years
5 secondary outcomes
Evaluate long term and acute toxicities of adjuvant chemotherapy and orbital irradiation if necessary.
Time frame: 5 years
Number of patient with secondary bilateralisation
Time frame: 5 years
Evaluate the different histopathological risk factors frequency
Time frame: 5 years
To determine tumors genomic
Time frame: at the inclusion
Evaluate sensitivity of MRI in detecting extra ocular extension
Time frame: At the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Observation, Etoposide and Vincristine in people with Retinoblastoma, run by Institut Curie at 27 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of extra ocular relapses (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.