Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
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.
Drug: liposomal vincristine sulfate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy|
- Event-free survival (EFS) [ Time Frame: At 2 years ] [ Designated as safety issue: No ]EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features (treated with adjuvant chemotherapy) and separately for subjects without high risk features (treated with enucleation alone).
- Overall survival (OS) [ Time Frame: At 2 years ] [ Designated as safety issue: No ]OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features (treated with adjuvant chemotherapy) and separately for subjects without high risk features (treated with enucleation alone). Survival data will be formally reviewed separately for subjects with and without high risk features for which adjuvant therapy is indicated, using the Lan-DeMets implementation of group sequential boundaries.
- Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]Toxicities associated with the adjuvant therapy for patients with high risk features will be descriptively summarized. The prevalence of well-defined, histopathologic features of interest will be summarized with descriptive statistics and 95% confidence intervals for proportions.
|Study Start Date:||December 2005|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Group 1 (chemotherapy)
Patients receive liposomal vincristine sulfate 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.
Drug: liposomal vincristine sulfate
Other Names:Drug: carboplatin
Other Names:Drug: etoposide
No Intervention: Group 2 (no intervention)
Patients undergo observation periodically for at least 5 years.
I. Prospectively determine the prevalence of high-risk histopathologic features, such as choroidal involvement, optic nerve invasion, and scleral and anterior segment involvement, in patients with newly diagnosed unilateral retinoblastoma who have undergone enucleation.
II. Demonstrate that patients without certain high-risk features can be successfully treated with enucleation alone by estimating the event-free survival (EFS) (where an event is defined as the occurrence of extraocular or metastatic disease) and overall survival (OS).
III. Estimate the EFS and OS of patients with specific high-risk features who are uniformly treated with adjuvant chemotherapy comprising vincristine, carboplatin, and etoposide.
IV. Estimate the incidence of toxicities associated with the proposed adjuvant chemotherapy regimen.
OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are assigned to 1 of 2 groups according to presence of high-risk histopathologic features.
GROUP 1 (high-risk features): Patients 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.
GROUP 2 (no high-risk features): Patients undergo observation periodically for at least 5 years.
After completion of study treatment, patients in group 1 are followed periodically for at least 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335738
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|Principal Investigator:||Murali Chintagumpala||Children's Oncology Group|