Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy
5 other identifiers
interventional
331
5 countries
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2005
Longer than P75 for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 8, 2006
CompletedFirst Posted
Study publicly available on registry
June 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedResults Posted
Study results publicly available
April 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedFebruary 18, 2021
March 1, 2018
5.8 years
June 8, 2006
December 2, 2015
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Event-free Survival (EFS)
EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.
At 2 years
Overall Survival (OS)
OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone.
At 2 Years
Secondary Outcomes (7)
Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
During planned six cycles of chemotherapy
Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)
At enrollment
Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding
At enrollment
Pathological Features Present at Diagnosis - Scleral Invasion (SI)
At enrollment
Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)
At enrollment
- +2 more secondary outcomes
Study Arms (2)
Group 1 (identified by central review as high risk)
EXPERIMENTALIncludes 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.
Group 2 (identified by central review as not high risk)
NO INTERVENTIONPatients undergo observation periodically for at least 5 years.
Interventions
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (56)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
Children's Oncology Group
Arcadia, California, 91006-3776, United States
Southern California Permanente Medical Group
Downey, California, 90242, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, 20057, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
University of Illinois
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital
Chicago, Illinois, 60614, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Maine Children's Cancer Program
Scarborough, Maine, 04074, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Wayne State University
Detroit, Michigan, 48202, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Covenant Children's Hospital
Lubbock, Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Childrens Hospital-King's Daughters
Norfolk, Virginia, 23507, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6008, Australia
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
L V Prasad Eye Institute
Hyderabad, 500 034, India
Starship Children's Hospital
Grafton, Auckland, 1145, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in 'Additional Description' is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Murali Chintagumpala, MD
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2006
First Posted
June 12, 2006
Study Start
December 1, 2005
Primary Completion
September 1, 2011
Study Completion
September 30, 2020
Last Updated
February 18, 2021
Results First Posted
April 17, 2018
Record last verified: 2018-03