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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335738 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Retinoblastoma |
Drug: carboplatin Drug: etoposide Drug: vincristine sulfate Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy |
Estimated Enrollment: | 600 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1 (high-risk features): Experimental
Patients receive vincristine IV and carboplatin IV over 1 hour on day 0 and etoposide IV over 1 hour on days 0 and 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: etoposide
Given IV
Drug: vincristine sulfate
Given IV
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Group 2 (no high-risk features): No Intervention
Patients undergo observation periodically for at least 5 years.
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Procedure: observation
Patients undergo observation periodically for at least 5 years.
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OBJECTIVES:
OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are assigned to 1 of 2 groups according to presence of high-risk histopathologic features.
After completion of study treatment, patients in group 1 are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Ages Eligible for Study: | up to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Underwent enucleation as primary therapy within the past 5 weeks
Disease with or without high-risk histopathologic features
High-risk features are defined as any of the following:
PATIENT CHARACTERISTICS:
Creatinine adjusted according to age as follows:
PRIOR CONCURRENT THERAPY:
Study Chair: | Murali M. Chintagumpala, MD | Texas Children's Cancer Center |
Investigator: | Joan O'Brien, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000483043, COG-ARET0332 |
Study First Received: | June 8, 2006 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00335738 |
Health Authority: | Unspecified |
intraocular retinoblastoma |
Retinal Neoplasms Eye Neoplasms Eye Diseases Vincristine Carboplatin Retinoblastoma Etoposide phosphate |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Etoposide Retinal Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic |