Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
NCT ID: NCT00335738
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2005-12-31
2020-09-30
Brief Summary
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Detailed Description
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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.
GROUP 3 (no consensus regarding high risk features can be reached): Patients undergo Group 1 chemotherapy or observation according to institutional high-risk feature assessment.
After completion of study treatment, patients in group 1 are followed periodically for at least 5 years.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (identified by central review as high risk)
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.
liposomal vincristine sulfate
Given IV
carboplatin
Given IV
etoposide
Given IV
Group 2 (identified by central review as not high risk)
Patients undergo observation periodically for at least 5 years.
No interventions assigned to this group
Interventions
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liposomal vincristine sulfate
Given IV
carboplatin
Given IV
etoposide
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
6 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Murali Chintagumpala, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Health Sciences Center
Tucson, Arizona, United States
Children's Oncology Group
Arcadia, California, United States
Southern California Permanente Medical Group
Downey, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
University of Illinois
Chicago, Illinois, United States
Childrens Memorial Hospital
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
The Childrens Mercy Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Brooklyn Hospital Center
Brooklyn, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Hospital Sainte-Justine
Montreal, Quebec, Canada
L V Prasad Eye Institute
Hyderabad, , India
Starship Children's Hospital
Grafton, Auckland, New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Countries
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Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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NCI-2009-00423
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000483043
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ARET0332
Identifier Type: OTHER
Identifier Source: secondary_id
ARET0332
Identifier Type: -
Identifier Source: org_study_id
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