Trial · NCT04681417
Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
NCT04681417, Phase 2, Phase 3, Recruiting, Institut Curie
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome. Trials, record NCT04681417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04681417
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome
- NCT number
- NCT04681417
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 225 participants, estimated
- Lead sponsor
- Institut Curie
- Conditions
- Retinoblastoma
- Interventions
Melphalan or Melphalan + Topotecan, etoposide, carboplatin and vincristine or local ophthalmological treatment without IV chemotherapy, Carboplatin administered on Day 1, Thermotherapy (local treatment), Cryotherapy (local treatment), Iodine-125 plaques (local treatment), Intravitreal Melphalan chemotherapy injections (local treatment)
- First posted
- 2020-12-23
- Last updated
- 2025-11-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study 1: Rate of eye preservation | 24 months after randomization | Rate of eye preservation in the 2 treatments' arms |
| Primary | Visual function | when patient is 6 years old and at least 24 months of follow-up after study inclusion | Percentage of patients with major, mild or no impairment of visual function according to WHO criteria, i.e. normal bilateral visual acuity (≥ 6/10) or mild bilateral visual impairment (3/10 to 5/10) according to tumor location and extension |
| Secondary | Ocular toxicity | Up to 24 months after inclusion in the study | Percentage of patients with at least one grade-3 or -4 toxicity (CTCAE v. 5.0) |
| Secondary | Systemic toxicity | Up to 24 months after inclusion in the study | Rate of specific grade 3-4 toxicity (CTCAE v. 5.0) |
| Secondary | Relapse | within 24 months after inclusion | Percentage of patients with relapse within 24 months after inclusion, broken down into: Local relapse, Extra-ocular relapse |
| Secondary | Second malignant tumor | 24 months after study inclusion | Percentage of patients with second malignant tumor within 24 months after study inclusion |
| Secondary | Additional assessment of visual function | In the year patients turn 6 years of age and at least 24 months of treatment | Additional assessment of visual function at follow-up: Percentage of patients at each of the four levels of visual acuity according to WHO criteria |
| Secondary | Retinal assessment | In the year patients turn 6 years of age and at least 24 months of treatment | Optical Coherence Tomography (OCT) and Optical Coherence Tomography-Angiography (OCT-A) measures on retina |
| Secondary | Integration at school | In the year patients turn 6 years of age and at least 24 months of treatment | Rate of children able to attend the common primary school : without specific help or with the help of a dedicated person and/or with specific features to facilitate reading and writing |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04681417
GET https://conductscience.org/api/trials/v1/NCT04681417/registered