Trial · NCT00079417
Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
NCT00079417, Phase 3, Completed, Children's Oncology Group; results first posted 2014-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma. Trials, record NCT00079417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00079417
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
- NCT number
- NCT00079417
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 28 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Intraocular Retinoblastoma
- Interventions
- Carboplatin, Cryosurgery, Infrared Laser Therapy, Iodine I-125, Radiation Therapy, Ruthenium Ru-106, Vincristine Sulfate
- First posted
- 2004-03-10
- Last updated
- 2023-03-13
- Results first posted
- 2014-02-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival | At 2 years | Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy. |
| Secondary | Response Rate (RR) at Patient Level After the First Course of Therapy | 1 month after enrollment | RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number of patients with Type I, II, III or IV response after first course of therapy |
| Secondary | Response Rate (RR) at Eye Levels After the First Course of Therapy | 1 month after enrollment | RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number eyes with Type I, II, III or IV response after first course of therapy |
| Secondary | Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level | 2 years after enrollment | EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction |
| Secondary | Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | 6 months after enrollment | Participants with Grade 3 and higher reported on protocol therapy |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival | At 2 years | All eligible patients are reported. 7 patients were excluded due to ineligible status. Of the 7 patients, 1 was determined to have only a Group A involved eye and the other 6 had an intact eye that was Group C or D. | Proportion of participants | NUMBER |
| SECONDARY | Response Rate (RR) at Patient Level After the First Course of Therapy | 1 month after enrollment | All eligible patients are reported. 7 patients were excluded due to ineligible status. | Proportion of participants | NUMBER |
| SECONDARY | Response Rate (RR) at Eye Levels After the First Course of Therapy | 1 month after enrollment | Number of Group B eyes for the eligible patients. 4 patients were excluded due to ineligible status. | Proportion of eyes | NUMBER |
| SECONDARY | Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level | 2 years after enrollment | There were 15 eligible patients who responded to vincristine and carboplatin after an initial 1 cycle of therapy. 7 patients were excluded due to ineligible status. | Proportion of participants | NUMBER |
| SECONDARY | Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | 6 months after enrollment | All eligible patients are reported. 7 patients were excluded due to ineligible status. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival | Vincristine Sulfate and Carboplatin and Surgery | 0.65 | 95% Confidence Interval 0.40 to 0.82 | Proportion of participants | |
| Response Rate (RR) at Patient Level After the First Course of Therapy | Vincristine Sulfate and Carboplatin and Surgery | 0.71 | 95% Confidence Interval 0.48 to 0.89 | Proportion of participants | |
| Response Rate (RR) at Eye Levels After the First Course of Therapy | Vincristine Sulfate and Carboplatin and Surgery | 0.71 | 95% Confidence Interval 0.49 to 0.87 | Proportion of eyes | |
| Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level | Vincristine Sulfate and Carboplatin and Surgery | 0.60 | 95% Confidence Interval 0.40 to 0.91 | Proportion of participants | |
| Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Vincristine Sulfate and Carboplatin and Surgery | Incidence of Catheter Related Infection | 1 | Participants | |
| Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Vincristine Sulfate and Carboplatin and Surgery | Incidence of Upper Respiratory Infection | 1 | Participants | |
| Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Vincristine Sulfate and Carboplatin and Surgery | Incidence of Dehydration | 1 | Participants | |
| Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Vincristine Sulfate and Carboplatin and Surgery | Incidence of Urticaria | 1 | Participants | |
| Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 | Vincristine Sulfate and Carboplatin and Surgery | Incidence of Neutrophils | 6 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vincristine Sulfate and Carboplatin and Surgery | 28 | |
| Overall Study | COMPLETED | Vincristine Sulfate and Carboplatin and Surgery | 19 | |
| Overall Study | NOT COMPLETED | Vincristine Sulfate and Carboplatin and Surgery | 9 |
Source ClinicalTrials.gov
Adverse events7
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 | Neutrophil count decreased | Investigations | Vincristine Sulfate and Carboplatin and Surgery | 1 | 21 | |
| other | Platelet count decreased | Investigations | Vincristine Sulfate and Carboplatin and Surgery | 2 | 21 | |
| serious | Catheter related infection | Infections and infestations | Vincristine Sulfate and Carboplatin and Surgery | 1 | 21 | |
| serious | Dehydration | Metabolism and nutrition disorders | Vincristine Sulfate and Carboplatin and Surgery | 1 | 21 | |
| serious | Neutrophil count decreased | Investigations | Vincristine Sulfate and Carboplatin and Surgery | 6 | 21 | |
| serious | Upper respiratory infection | Infections and infestations | Vincristine Sulfate and Carboplatin and Surgery | 1 | 21 | |
| serious | Urticaria | Skin and subcutaneous tissue disorders | Vincristine Sulfate and Carboplatin and Surgery | 1 | 21 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vincristine Sulfate and Carboplatin and Surgery | ||
| Total, other adverse events | Vincristine Sulfate and Carboplatin and Surgery | 3 | 21 |
| Total, serious adverse events | Vincristine Sulfate and Carboplatin and Surgery | 10 | 21 |
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/NCT00079417
GET https://conductscience.org/api/trials/v1/NCT00079417/registered