RetinoblastomaPhase 2RETINO2011NCT02866136
Conservative Treatments of Retinoblastoma
A Phase 2 study testing VP16, carboplatin, Melphalan and VP16, carboplatin, vincristin in people with Retinoblastoma and Children, run by Institut Curie at 1 site in France.
Trial summary
Conservative treatments of retinoblastoma (RETINO 2011) 1. -Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8 2. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Retinoblastoma, Children, Retinal Neoplasm
- What is being tested?
- VP16, carboplatin, Melphalan and VP16, carboplatin, vincristin
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Sep 2035
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Study 1 inclusion criteria:
- Patients affected by unilateral retinoblastoma groups A, B (according to the age), group C (according to the age and vitreous seeding),or bilateral retinoblastoma groups A, B, C (excluding the eyes with macular threat and bilateral group D eyes or on the only remaining eye) amenable to a conservative treatment (at least on one eye in bilateral disease) but needing initial chemotherapy because of the location, the size of the lesion (more than 4 mm of diameter), a vision threat or risks of intravitreal relapse making those patients not amenable to chemothermotherapy first line.
- Patients less than six months of age with unilateral retinoblastoma groups B, C, D, or bilateral very asymmetric with one eye group D and the other amenable to local treatments without chemotherapy.
- Children from 0 to 6 years old.
- Study 2 inclusion criteria:
- Patients affected by unilateral or bilateral retinoblastoma group B (according to the age), group C (according to the age and vitreous seeding), or group D.
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- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
- Children from 6 months to 6 years old.
- Study 3 inclusion criteria:
- Children affected of bilateral group D retinoblastoma or on the only eye amenable to conservative treatment.
- Children from 0 to 6 years old.
- Common inclusion criteria:
- Patients not previously treated by chemotherapy or radiotherapy for this tumour or another cancer.
- No contra-indications to the study treatments
- Possible long term follow-up.
- Written informed consent of the parents or the legal representative.
- Patients having social security cover.
Who cannot join
- Study 1 exclusion criteria:
- Patients for whom a local treatment is possible without initial chemotherapy (tumour smaller than 4 mm and located far from optic nerve head or macula).
- Patients with an unilateral group D with massive tumour or group E eyes needing enucleation first line or after initial chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
- Patients with bilateral retinoblastoma and bilateral group D eyes or on the only remaining eye or presenting a bilateral macular threat requiring conservative treatment by a 6 cycles, three drugs regimen.
- Study 2 exclusion criteria:
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- Patients with a unilateral group D (extensive) or B or C but covering the optic nerve head or group E eyes for which enucleation is warranted first line or after chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
- Patients with unilateral group D eye with tumour volume of more than 50% of eye volume, for whom a massive choroidal invasion could be associated (on clinical or imaging criteria) and for which enucleation is warranted.
- Study 3 exclusion criteria:
- Patients for whom a local treatment is possible without chemoreduction (tumour smaller than 4 mm, distant from macula and from optic nerve head).
- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
- Patients with bilateral retinoblastoma without macular threat or groups A, B, C than can be treated with chemoreduction by VP16 and Carboplatin then chemothermotherapy without laser at day 8.
- Common exclusion criteria:
- Patients older than 6 years old.
- Patients with extraocular retinoblastoma.
- Patients with a disease being a contra-indication to chemotherapy.
- Patients anteriorly treated by chemotherapy.
- Patients anteriorly treated by external beam irradiation.
- Patients anteriorly treated for another cancer.
- Follow-up not possible due to geographic distance from the center or for social or psychological reasons.
- Parents not having accepted the therapeutic strategy after explanations by the investigator.
- Contra-indication to the use of one of the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Conservative treatments of retinoblastoma (RETINO 2011)
- -Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8
- -Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding
- - Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.
- Conditions
- Retinoblastoma, Children, Retinal Neoplasm
- Being tested
- VP16, carboplatin, Melphalan, VP16, carboplatin, vincristin, Carboplatin + laser day 1 (chemothermotherapy), Laser (local treatment)
- Medical subject headings
- Retinoblastoma, Retinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VP16, carboplatinDrug
Also called etoposide, vepesid, chemotherapy
Systemic treatment : Intravenous injections, 2 cycles (21 days)
MelphalanDrug
Also called Alkeran, chemotherapy
intraarterial injections, 3 to 6 cycles (1 month)
VP16, carboplatin, vincristinDrug
Also called etoposide, vepesid, leurocristine, Oncovin, chemotherapy
Systemic treatment : Intravenous injections, 6 cycles (21 days)
Carboplatin + laser day 1 (chemothermotherapy)Drug
Also called Carbo-laser, platinum-based chemotherapy
Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1
Laser (local treatment)Device
Also called Laser diode
cryoapplication (local treatment)Device
I125 radioactive plaques (local treatment)Radiation
intravitreal Melphalan (local treatment)Drug
| Study group | Role | What they receive |
|---|---|---|
| (IV)Intravenous chemotherapy, laser diode | Other | Group 1 - Multicentric non randomised, phase II study for patients with retinoblastoma (unilateral group A,B according to age, group C according to the age and the vitreous seeding or bilateral groups A,B and C excluding the bilateral groups D or patients with bilateral macular threat).
Treatment by chemoreduction (VP16, carboplatin) followed by Carboplatin + laser day 1 (chemothermotherapy) without laser treatment at day 8 (decreasing laser sessions) combined to local treatments from third course (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan). Receives: Drug: VP16, carboplatin; Drug: Carboplatin + laser day 1 (chemothermotherapy); Device: Laser (local treatment); Device: cryoapplication (local treatment); Radiation: I125 radioactive plaques (local treatment); Drug: intravitreal Melphalan (local treatment) |
| (IA) Intraarterial Melphalan | Other | Group 2 - Multicentric non randomised, phase II study for the patients with bilateral very asymmetric disease (group D retinoblastoma on one of the eye, and the other amenable to a local treatment without chemotherapy) or unilateral presentation group D and groups B/C according to the age and vitreous seeding.
Treatment by Melphalan chemotherapy administered by superselective catheterization of the ophthalmic artery and combined to local treatments (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan). Receives: Drug: Melphalan; Device: Laser (local treatment); Device: cryoapplication (local treatment); Radiation: I125 radioactive plaques (local treatment); Drug: intravitreal Melphalan (local treatment) |
| (IV-PM) Intravenous 3 drugs chemotherapy | Other | Group 3 - Multicentric non randomised, phase II study for the patients with bilateral group D retinoblastoma or with a group D retinoblastoma on the only remaining eye. Treatment by 6 cycles of three drugs (VP16, carboplatin, vincristin) regimen combined to local treatments from the third cycle (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan). Receives: Drug: VP16, carboplatin, vincristin; Device: Laser (local treatment); Device: cryoapplication (local treatment); Radiation: I125 radioactive plaques (local treatment); Drug: intravitreal Melphalan (local treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enucleation and external beam irradiation
Measured: From first day of treatment to 18 months after the end of treatments
Secondary outcomes (6)
Number of relapses diagnosticated by fundus examination under general anesthesia until the age of 4 years, and without general anesthesia for older patients
Number of fundus examination positives without clinical symptoms and number of patients treated after fundus examination-related treatment with a controlled disease.
Measured: 5 years
Prospective evaluation of the systemic, ocular and general sides effects (short term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 and types of adverse events occuring in order to reassess the benefice-risk scale (by Independent Data Monitoring Committee), for each arm of the study and for the whole study.
Measured: 5 years
Prospective evaluation of the systemic, ocular and general sides effects (medium and long term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan
Rate of patient with a progression disease and/or presenting a medium/long term adverse event(s) or a second cancer.
Measured: 5 years
Response to intravitreal chemotherapy by Melphalan
Number of patients with uncontrolled disease (progression) and/or presenting Adverse Event(s) as assessed by CTCAE v4.0, related to intravitreal chemotherapy by Melphalan.
Measured: 18 months
Radiation doses received during intraarterial procedures
Time of scopies during ophthalmic arterial catheterism, doses delivered by the machine, doses received on skin.
Measured: 18 months
Number of patients presenting a long term second tumour
Measured: until 20 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startFeb 2012
- Primary completionJan 2023
- Study completionSep 2035 (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
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Rothschild Paris
- Responsible party
- Sponsor
- Investigators
- Isabelle Aerts, MD, Study director, Institut Curie - Paris - FranceCatherine Devoldere, MD, Principal investigator, Amiens (FR), University College HospitalIsabelle Pellier, MD, Principal investigator, Angers (FR), University College HospitalVéronique Laithier, MD, Principal investigator, Besançon (FR), Jean Minjoz HospitalCeline De Bouyn-Icher, MD, Principal investigator, Bordeaux (FR), Pellegrin Regional HospitalLiana-Stephania Carausau, MD, Principal investigator, Brest (FR), University College HospitalDamien BODET, MD, Principal investigator, Caen (FR), University College HospitalJustyna Kanold, MD, Principal investigator, Clermont-Ferrand (FR), University College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866136
- Sponsor's protocol ID
- IC 2011-05
- Acronym
- RETINO2011
- Status last verified
- Nov 2025
- First submitted
- 27 Jul 2016
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatments of Retinoblastoma
- ClinicalTrials.gov ID
- NCT02866136
- Acronym / sponsor ID
- RETINO2011 / IC 2011-05
- Conditions
- Retinoblastoma, Children, Retinal Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Fondation Rothschild Paris
- Study start
- Feb 2012 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Sep 2035 (estimated)
- First posted
- 15 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.
Conservative treatments of retinoblastoma (RETINO 2011)
- -Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8
- -Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding
- - Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (IV)Intravenous chemotherapy, laser diode | Other | Drug: VP16, carboplatin, Drug: Carboplatin + laser day 1 (chemothermotherapy), Device: Laser (local treatment), Device: cryoapplication (local treatment), Radiation: I125 radioactive plaques (local treatment), Drug: intravitreal Melphalan (local treatment)Group 1 - Multicentric non randomised, phase II study for patients with retinoblastoma (unilateral group A,B according to age, group C according to the age and the vitreous seeding or bilateral groups A,B and C excluding the bilateral groups D or patients with bilateral macular threat). Treatment by chemoreduction (VP16, carboplatin) followed by Carboplatin + laser day 1 (chemothermotherapy) without laser treatment at day 8 (decreasing laser sessions) combined to local treatments from third course (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan). |
| (IA) Intraarterial Melphalan | Other | Drug: Melphalan, Device: Laser (local treatment), Device: cryoapplication (local treatment), Radiation: I125 radioactive plaques (local treatment), Drug: intravitreal Melphalan (local treatment)Group 2 - Multicentric non randomised, phase II study for the patients with bilateral very asymmetric disease (group D retinoblastoma on one of the eye, and the other amenable to a local treatment without chemotherapy) or unilateral presentation group D and groups B/C according to the age and vitreous seeding. Treatment by Melphalan chemotherapy administered by superselective catheterization of the ophthalmic artery and combined to local treatments (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan). |
| (IV-PM) Intravenous 3 drugs chemotherapy | Other | Drug: VP16, carboplatin, vincristin, Device: Laser (local treatment), Device: cryoapplication (local treatment), Radiation: I125 radioactive plaques (local treatment), Drug: intravitreal Melphalan (local treatment)Group 3 - Multicentric non randomised, phase II study for the patients with bilateral group D retinoblastoma or with a group D retinoblastoma on the only remaining eye. Treatment by 6 cycles of three drugs (VP16, carboplatin, vincristin) regimen combined to local treatments from the third cycle (laser, cryoapplication, I125 radioactive plaques or intravitreal Melphalan). |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Patients affected by unilateral retinoblastoma groups A, B (according to the age), group C (according to the age and vitreous seeding),or bilateral retinoblastoma groups A, B, C (excluding the eyes with macular threat and bilateral group D eyes or on the only remaining eye) amenable to a conservative treatment (at least on one eye in bilateral disease) but needing initial chemotherapy because of the location, the size of the lesion (more than 4 mm of diameter), a vision threat or risks of intravitreal relapse making those patients not amenable to chemothermotherapy first line.
- Patients less than six months of age with unilateral retinoblastoma groups B, C, D, or bilateral very asymmetric with one eye group D and the other amenable to local treatments without chemotherapy.
- Children from 0 to 6 years old.
- Patients affected by unilateral or bilateral retinoblastoma group B (according to the age), group C (according to the age and vitreous seeding), or group D.
- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
Key exclusion criteria (22 listed)
- Patients for whom a local treatment is possible without initial chemotherapy (tumour smaller than 4 mm and located far from optic nerve head or macula).
- Patients with an unilateral group D with massive tumour or group E eyes needing enucleation first line or after initial chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
- Patients affected by bilateral retinoblastoma very asymmetric with a group D eye that can be treated by intraarterial chemotherapy by Melphalan and the other amenable to local treatments without chemotherapy.
- Patients with bilateral retinoblastoma and bilateral group D eyes or on the only remaining eye or presenting a bilateral macular threat requiring conservative treatment by a 6 cycles, three drugs regimen.
- Patients with a unilateral group D (extensive) or B or C but covering the optic nerve head or group E eyes for which enucleation is warranted first line or after chemotherapy (in case of buphthalmia or suspected optic nerve invasion or extrascleral extension).
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 |
|---|---|---|
| VP16, carboplatinAlso: etoposide, vepesid, chemotherapySystemic treatment : Intravenous injections, 2 cycles (21 days) | Drug | (IV)Intravenous chemotherapy, laser diode |
| MelphalanAlso: Alkeran, chemotherapyintraarterial injections, 3 to 6 cycles (1 month) | Drug | (IA) Intraarterial Melphalan |
| VP16, carboplatin, vincristinAlso: etoposide, vepesid, leurocristine, Oncovin, chemotherapySystemic treatment : Intravenous injections, 6 cycles (21 days) | Drug | (IV-PM) Intravenous 3 drugs chemotherapy |
| Carboplatin + laser day 1 (chemothermotherapy)Also: Carbo-laser, platinum-based chemotherapyChemothermotherapy : Intravenous injection by carboplatin and Laser at day 1 | Drug | (IV)Intravenous chemotherapy, laser diode |
| Laser (local treatment)Also: Laser diode | Device | (IA) Intraarterial Melphalan, (IV)Intravenous chemotherapy, laser diode, (IV-PM) Intravenous 3 drugs chemotherapy |
| cryoapplication (local treatment) | Device | (IA) Intraarterial Melphalan, (IV)Intravenous chemotherapy, laser diode, (IV-PM) Intravenous 3 drugs chemotherapy |
| I125 radioactive plaques (local treatment) | Radiation | (IA) Intraarterial Melphalan, (IV)Intravenous chemotherapy, laser diode, (IV-PM) Intravenous 3 drugs chemotherapy |
| intravitreal Melphalan (local treatment) | Drug | (IA) Intraarterial Melphalan, (IV)Intravenous chemotherapy, laser diode, (IV-PM) Intravenous 3 drugs chemotherapy |
Primary outcome
Rate of enucleation and external beam irradiation
Time frame: From first day of treatment to 18 months after the end of treatments
6 secondary outcomes
Number of relapses diagnosticated by fundus examination under general anesthesia until the age of 4 years, and without general anesthesia for older patients
Time frame: 5 years
Prospective evaluation of the systemic, ocular and general sides effects (short term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan
Time frame: 5 years
Prospective evaluation of the systemic, ocular and general sides effects (medium and long term) of the intravenous chemotherapy, intraarterial chemotherapy, combined to the local treatments as well as the intravitreal injections of Melphalan
Time frame: 5 years
Response to intravitreal chemotherapy by Melphalan
Time frame: 18 months
Radiation doses received during intraarterial procedures
Time frame: 18 months
Number of patients presenting a long term second tumour
Time frame: until 20 years old
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 24 Nov 2025.
- 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.
Isabelle Aerts, MD study director
Institut Curie - Paris - France
Catherine Devoldere, MD principal investigator
Amiens (FR), University College Hospital
Isabelle Pellier, MD principal investigator
Angers (FR), University College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VP16, carboplatin, Melphalan and VP16, carboplatin, vincristin in people with Retinoblastoma and Children, run by Institut Curie at 1 site 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 17 inclusion and 22 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 enucleation and external beam irradiation (time frame: From first day of treatment to 18 months after the end of treatments). 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 24 Nov 2025.