Trial · NCT00335738
Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
NCT00335738, Phase 3, Completed, Children's Oncology Group; results first posted 2018-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma. Trials, record NCT00335738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00335738
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
- NCT number
- NCT00335738
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 331 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Intraocular Retinoblastoma
- Interventions
- liposomal vincristine sulfate, carboplatin, etoposide
- First posted
- 2006-06-12
- Last updated
- 2021-02-18
- Results first posted
- 2018-04-17
- Limitations and caveats
The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in 'Additional Description' is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | At 2 years | EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone. |
| Primary | Overall Survival (OS) | At 2 Years | OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone. |
| Secondary | Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | During planned six cycles of chemotherapy | Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity. |
| Secondary | Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI) | At enrollment | Proportion of patients who had posterior uveal invasion at enrollment. |
| Secondary | Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding | At enrollment | Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent. |
| Secondary | Pathological Features Present at Diagnosis - Scleral Invasion (SI) | At enrollment | Proportion of patients that had scleral invasion at enrollment. |
| Secondary | Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS) | At enrollment | Proportion of patients who had anterior chamber seeding at enrollment. |
| Secondary | Pathological Features Present At Diagnosis - Iris Infiltration (II) | At enrollment | Proportion of patients who had iris infiltration at enrollment. |
| Secondary | Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI) | At Enrollment | Proportion of patients who had ciliary body infiltration at enrollment. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS) | At 2 years | Only eligible patients are considered in the characterization of EFS at 2 years. | Estimated Probability | NUMBER |
| PRIMARY | Overall Survival (OS) | At 2 Years | Only eligible patients are considered for this outcome measure. This is calculated as the total number of patients enrolled in each group with the number ineligible in each group subtracted as reported on the participant flow template. | Estimated Probability | NUMBER |
| SECONDARY | Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | During planned six cycles of chemotherapy | Adverse experiences as coded using CTC AE version 4 were collected only for patients who received chemotherapy according to protocol guidelines. Of the 105 eligible patients with high risk features, ninety-three (93) were given protocol chemotherapy based on the assessment of the central pathology review, as described in section 4 of the ARET0332. | participants | NUMBER |
| SECONDARY | Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI) | At enrollment | Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow. | Proportion of patients with PVI | NUMBER |
| SECONDARY | Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding | At enrollment | Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow. | Proportion of patients with LC | NUMBER |
| SECONDARY | Pathological Features Present at Diagnosis - Scleral Invasion (SI) | At enrollment | Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow. | Proportion of patients with SI | NUMBER |
| SECONDARY | Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS) | At enrollment | Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow. | Proportion of patients with ACS | NUMBER |
| SECONDARY | Pathological Features Present At Diagnosis - Iris Infiltration (II) | At enrollment | Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow. | Proportion of patients with II | NUMBER |
| SECONDARY | Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI) | At Enrollment | Central review of the biological materials for this aim was available on only 313 patients. This outcome measure is calculated by combing all groups as characterized in the Patient Flow. | Proportion of patients with CBI | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free Survival (EFS) | Group 1 (Identified by Central Review as High Risk) | 0.9394 | 95% Confidence Interval 0.8606 to 0.9743 | Estimated Probability | |
| Event-free Survival (EFS) | Group 2 (Identified by Central Review as Not High Risk) | 0.9953 | 95% Confidence Interval 0.9671 to 0.9993 | Estimated Probability | |
| Overall Survival (OS) | Group 1 (Identified by Central Review as High Risk) | 0.9628 | 95% Confidence Interval 0.8890 to 0.9878 | Estimated Probability | |
| Overall Survival (OS) | Group 2 (Identified by Central Review as Not High Risk) | 1 | 95% Confidence Interval 1 to 1 | Estimated Probability | |
| Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Group 1 (Identified by Central Review as High Risk) | 19 | participants | ||
| Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI) | All Patients | 0.24 | 95% Confidence Interval 0.19 to 0.29 | Proportion of patients with PVI | |
| Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding | All Patients | 0.16 | 95% Confidence Interval 0.12 to 0.21 | Proportion of patients with LC | |
| Pathological Features Present at Diagnosis - Scleral Invasion (SI) | All Patients | 0.016 | 95% Confidence Interval 0.0052 to 0.037 | Proportion of patients with SI | |
| Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS) | All Patients | 0.045 | 95% Confidence Interval 0.025 to 0.074 | Proportion of patients with ACS | |
| Pathological Features Present At Diagnosis - Iris Infiltration (II) | All Patients | 0.029 | 95% Confidence Interval 0.013 to 0.054 | Proportion of patients with II |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (Identified by Central Review as High Risk) | 108 | |
| Overall Study | STARTED | Group 2 (Identified by Central Review as Not High Risk) | 223 | |
| Overall Study | COMPLETED | Group 1 (Identified by Central Review as High Risk) | 97 | |
| Overall Study | COMPLETED | Group 2 (Identified by Central Review as Not High Risk) | 219 | |
| Overall Study | NOT COMPLETED | Group 1 (Identified by Central Review as High Risk) | 11 | |
| Overall Study | NOT COMPLETED | Group 2 (Identified by Central Review as Not High Risk) | 4 |
Source ClinicalTrials.gov
Adverse events36
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 | Alanine aminotransferase increased | Investigations | Group 1 (Identified by Central Review as High Risk) | 1 | 93 | |
| other | Alanine aminotransferase increased | Investigations | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 | |
| other | Anaphylaxis | Immune system disorders | Group 1 (Identified by Central Review as High Risk) | 5 | 93 | |
| other | Anaphylaxis | Immune system disorders | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 | |
| other | Anemia | Blood and lymphatic system disorders | Group 1 (Identified by Central Review as High Risk) | 2 | 93 | |
| other | Anemia | Blood and lymphatic system disorders | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 | |
| other | Anorexia | Metabolism and nutrition disorders | Group 1 (Identified by Central Review as High Risk) | 1 | 93 | |
| other | Anorexia | Metabolism and nutrition disorders | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 | |
| other | Aspartate aminotransferase increased | Investigations | Group 1 (Identified by Central Review as High Risk) | 1 | 93 | |
| other | Aspartate aminotransferase increased | Investigations | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (Identified by Central Review as High Risk) | 0 | 93 |
| Total, all-cause mortality | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 |
| Total, other adverse events | Group 1 (Identified by Central Review as High Risk) | 19 | 93 |
| Total, other adverse events | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 |
| Total, serious adverse events | Group 1 (Identified by Central Review as High Risk) | 0 | 93 |
| Total, serious adverse events | Group 2 (Identified by Central Review as Not High Risk) | 0 | 0 |
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/NCT00335738
GET https://conductscience.org/api/trials/v1/NCT00335738/events?page=2