Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
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|ClinicalTrials.gov Identifier: NCT00335738|
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : June 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Retinoblastoma||Drug: liposomal vincristine sulfate Drug: carboplatin Drug: etoposide||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||331 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy|
|Study Start Date :||December 2005|
|Primary Completion Date :||September 2011|
U.S. FDA Resources
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.
- Event-free survival (EFS) [ Time Frame: At 2 years ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335738
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|Principal Investigator:||Murali Chintagumpala||Children's Oncology Group|