Phase 3
N=331
Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
Intraocular Retinoblastoma
Bottom Line
View on ClinicalTrials.gov: NCT00335738 ↗Enrolled (actual)
331
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Event-free Survival (EFS) — 0.9394; 0.9953 Estimated Probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- liposomal vincristine sulfate (Drug); carboplatin (Drug); etoposide (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival (EFS) |
0.9394; 0.9953 | — |
| PRIMARY Overall Survival (OS) |
0.9628; 1 | — |
| SECONDARY Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
19 | — |
| SECONDARY Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI) |
0.24 | — |
| SECONDARY Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding |
0.16 | — |
| SECONDARY Pathological Features Present at Diagnosis - Scleral Invasion (SI) |
0.016 | — |
| SECONDARY Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS) |
0.045 | — |
| SECONDARY Pathological Features Present At Diagnosis - Iris Infiltration (II) |
0.029 | — |
| SECONDARY Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI) |
0.019 | — |
Summary
This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, no additional treatment is needed for the tumor until it progresses. In this case, observation may be sufficient.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed unilateral retinoblastoma
- Underwent enucleation as primary therapy within the past 5 weeks
- Must enroll and submit pathology slides within 21 days of enucleation
- Adjuvant chemotherapy must begin within 35 days after enucleation
- Disease with or without high-risk histopathologic features
- High-risk features are defined as any of the following:
- Posterior uveal invasion (includes choroidal invasion)
- Any degree of concomitant choroid and/or optic nerve involvement
- Tumor involving the optic nerve posterior to the lamina cribrosa as an independent finding
- Scleral invasion
- Anterior chamber seeding
- Ciliary body infiltration
- Iris infiltration
- No evidence of extraocular retinoblastoma clinically, by CT scan, or by MRI of the brain and orbits with and without gadolinium
- No tumor at the cut end of the optic nerve on any eye enucleated as evidenced by histologic examination prior to study entry
- No systemic metastases as evidenced by bone marrow scan, bone scan, or any other additional test at study entry
- Lansky performance status 50-100%
- Hemoglobin > 8 g/dL
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine adjusted according to age as follows:
- No greater than 0.4 mg/dL (≤ 5 months)
- No greater than 0.5 mg/dL (6 months -11 months)
- No greater than 0.6 mg/dL (1 year-23 months)
- No greater than 0.8 mg/dL (2 years-5 years)
- No greater than 1.0 mg/dL (6 years-9 years)
- No greater than 1.2 mg/dL (10 years-12 years)
- No greater than 1.4 mg/dL (13 years and over [female])
- No greater than 1.5 mg/dL (13 years to 15 years [male])
- No greater than 1.7 mg/dL (16 years and over [male])
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- AST or ALT < 2.5 times ULN for age
- No prior therapy other than enucleation
- No prior chemotherapy
Data sourced from ClinicalTrials.gov (NCT00335738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.