Trial · NCT00072384
Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma
NCT00072384, Phase 3, Completed, Children's Oncology Group; results first posted 2018-09-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma. Trials, record NCT00072384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00072384
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma
- NCT number
- NCT00072384
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Intraocular Retinoblastoma
- Interventions
- liposomal vincristine sulfate, cryosurgery, laser surgery, carboplatin, etoposide, filgrastim
- First posted
- 2003-11-06
- Last updated
- 2021-07-30
- Results first posted
- 2018-09-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Group D Eyes - Treatment Failure Within One Year | One year | Each Group D eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the "Mean" measure type. |
| Primary | Group C Eyes - Treatment Failure Within One Year | One year | Each Group C eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the "Mean" measure type. |
| Secondary | Event-free Survival (EFS) | One year after study enrollment | Proportion of patients event free at 1 year following enrollment. Event free survival time is computed as the time to study entry until disease relapse/progression, secondary malignancy, or death. |
| Secondary | Toxicity Associated With Chemotherapy | From date of enrollment until termination of protocol therapy assessed up to 72 weeks | The number of patients that experience CTC Version 4 grade 3 or higher toxicities of any kind. |
| Secondary | Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | From the date of enrollment assessed up to 36 months | Sites of disease recurrence for Group C and Group D eyes where treatment failure was detected |
| Secondary | Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement | From the date of enrollment assessed up to 12 months | The association between the probability of experiencing treatment failure vs. no failure in a C eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia. The association between the probability of experiencing treatment failure vs. no failure in a D eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Group D Eyes - Treatment Failure Within One Year | One year | Twenty eligible patients had at least one Group D eye to contribute to the analysis. A total of 25 Group D eyes were available for analysis. | Probability of treatment failure | MEAN |
| PRIMARY | Group C Eyes - Treatment Failure Within One Year | One year | Four eligible patients had at least one Group C eye to contribute to the analysis | Probability of treatment failure | MEAN |
| SECONDARY | Event-free Survival (EFS) | One year after study enrollment | 22 eligible patients were considered for this endpoint. | Percentage probability | NUMBER |
| SECONDARY | Toxicity Associated With Chemotherapy | From date of enrollment until termination of protocol therapy assessed up to 72 weeks | 22 eligible patients were evaluable for the occurrence of grade 3 or higher toxicity of any kind. | Patients | NUMBER |
| SECONDARY | Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | From the date of enrollment assessed up to 36 months | 1 patient had at least one Group C eye and 11 patients had at least one Group D eye that experienced treatment failure. There were a total of 13 Group D eyes that experienced treatment failure. | Eyes | NUMBER |
| SECONDARY | Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement | From the date of enrollment assessed up to 12 months | According to the initial sites of involvement, 4 patients were analyzed in Group C eyes and 20 patients were analyzed for Group D eyes | Eyes | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Group D Eyes - Treatment Failure Within One Year | Treatment (Chemotherapy, Surgery) | 0.52 | Standard Deviation 0.102299 | Probability of treatment failure | |
| Group C Eyes - Treatment Failure Within One Year | Treatment (Chemotherapy, Surgery) | 0.25 | Standard Deviation 0.217 | Probability of treatment failure | |
| Event-free Survival (EFS) | Treatment (Chemotherapy, Surgery) | 45.45 | 95% Confidence Interval 24.44 to 64.33 | Percentage probability | |
| Toxicity Associated With Chemotherapy | Treatment (Chemotherapy, Surgery) | 10 | Patients | ||
| Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | Group C Eyes | Retinal seeding and vitreal seeding | 0 | Eyes | |
| Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | Group D Eyes | Retinal seeding and vitreal seeding | 1 | Eyes | |
| Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | Group C Eyes | Retinal seeding but no vitreal seeding | 1 | Eyes | |
| Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | Group D Eyes | Retinal seeding but no vitreal seeding | 7 | Eyes | |
| Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | Group C Eyes | Vitreal seeding but no retinal seeding | 0 | Eyes | |
| Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence | Group D Eyes | Vitreal seeding but no retinal seeding | 1 | Eyes |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Chemotherapy, Surgery) | 30 | |
| Overall Study | COMPLETED | Treatment (Chemotherapy, Surgery) | 21 | |
| Overall Study | NOT COMPLETED | Treatment (Chemotherapy, Surgery) | 9 |
Source ClinicalTrials.gov
Adverse events13
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anorectal infection | Infections and infestations | Treatment (Chemotherapy, Surgery) | 1 | 22 | |
| other | Bladder infection | Infections and infestations | Treatment (Chemotherapy, Surgery) | 1 | 22 | |
| other | Device related infection | Infections and infestations | Treatment (Chemotherapy, Surgery) | 1 | 22 | |
| other | Eye disorders - Other, specify | Eye disorders | Treatment (Chemotherapy, Surgery) | 2 | 22 | |
| other | Eye infection | Infections and infestations | Treatment (Chemotherapy, Surgery) | 1 | 22 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Chemotherapy, Surgery) | 1 | 22 | |
| other | Hearing impaired | Ear and labyrinth disorders | Treatment (Chemotherapy, Surgery) | 2 | 22 | |
| other | Infections and infestations - Other, specify | Infections and infestations | Treatment (Chemotherapy, Surgery) | 2 | 22 | |
| other | Lung infection | Infections and infestations | Treatment (Chemotherapy, Surgery) | 1 | 22 | |
| other | Middle ear inflammation | Ear and labyrinth disorders | Treatment (Chemotherapy, Surgery) | 1 | 22 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Chemotherapy, Surgery) | ||
| Total, other adverse events | Treatment (Chemotherapy, Surgery) | 18 | 22 |
| Total, serious adverse events | Treatment (Chemotherapy, Surgery) | 0 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
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/NCT00072384
GET https://conductscience.org/api/trials/v1/NCT00072384/results?page=2