TriangleNCT00335738 · STUDY IN CONTEXT
Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity.
Proportion of patients who had posterior uveal invasion at enrollment.
Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent.
Proportion of patients that had scleral invasion at enrollment.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- trial label
- Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0000
- source section id
- NCT00335738-om-0000
- source outcome index
- 0
- endpoint
- Event-free Survival (EFS)
- endpoint definition
- 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.
- time origin
- At 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only eligible patients are considered in the characterization of EFS at 2 years.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0001
- source section id
- NCT00335738-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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.
- time origin
- At 2 Years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0002
- source section id
- NCT00335738-om-0002
- source outcome index
- 2
- endpoint
- Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
- endpoint definition
- Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity.
- time origin
- During planned six cycles of chemotherapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0003
- source section id
- NCT00335738-om-0003
- source outcome index
- 3
- endpoint
- Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)
- endpoint definition
- Proportion of patients who had posterior uveal invasion at enrollment.
- time origin
- At enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0004
- source section id
- NCT00335738-om-0004
- source outcome index
- 4
- endpoint
- Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding
- endpoint definition
- Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent.
- time origin
- At enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0005
- source section id
- NCT00335738-om-0005
- source outcome index
- 5
- endpoint
- Pathological Features Present at Diagnosis - Scleral Invasion (SI)
- endpoint definition
- Proportion of patients that had scleral invasion at enrollment.
- time origin
- At enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Group 1 (Identified by Central Review as High Risk)
- regimen
- Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
- analyzed count
- 89
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Group 2 (Identified by Central Review as Not High Risk)
- regimen
- Patients undergo observation periodically for at least 5 years.
- analyzed count
- 235
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Group 1 (Identified by Central Review as High Risk)
- regimen
- Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
- analyzed count
- 89
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Group 2 (Identified by Central Review as Not High Risk)
- regimen
- Patients undergo observation periodically for at least 5 years.
- analyzed count
- 235
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Group 1 (Identified by Central Review as High Risk)
- regimen
- Includes patients who may or may not require chemotherapy. Patients who require chemotherapy receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity and patients who complete chemotherapy are followed after completion of therapy periodically for at least 5 years. Patients who do not require chemotherapy undergo observation periodically for at least 5 years.
- analyzed count
- 93
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Patients
- regimen
- This outcome measure is calculated by combining all groups as defined in the trials record.
- analyzed count
- 313
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0004
- arm key
- OG000
- arm label
- All Patients
- regimen
- This outcome measure is calculated by combining all groups as defined in the trials record.
- analyzed count
- 313
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- outcome key
- om-0005
- arm key
- OG000
- arm label
- All Patients
- regimen
- This outcome measure is calculated by combining all groups as defined in the trials record.
- analyzed count
- 313
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00335738-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- harm key
- EG000
- source section id
- NCT00335738-ae
- event group key
- EG000
- event group label
- Group 1 (Identified by Central Review as High Risk)
- serious affected
- 0
- serious at risk
- 93
- other affected
- 19
- other at risk
- 93
- frequency threshold
- 0
- collection period
- Source null
- event definition
- 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 protocol.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-retinoblastoma
- nct id
- NCT00335738
- harm key
- EG001
- source section id
- NCT00335738-ae
- event group key
- EG001
- event group label
- Group 2 (Identified by Central Review as Not High Risk)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Source null
- event definition
- 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 protocol.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice