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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00335738




Registration number
NCT00335738
Ethics application status
Date submitted
8/06/2006
Date registered
12/06/2006
Date last updated
18/02/2021

Titles & IDs
Public title
Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma
Scientific title
A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy
Secondary ID [1] 0 0
NCI-2009-00423
Secondary ID [2] 0 0
ARET0332
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraocular Retinoblastoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Head and neck
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liposomal vincristine sulfate
Treatment: Drugs - carboplatin
Treatment: Drugs - etoposide

Experimental: 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.

No intervention: Group 2 (identified by central review as not high risk) - Patients undergo observation periodically for at least 5 years.


Treatment: Drugs: liposomal vincristine sulfate
Given IV

Treatment: Drugs: carboplatin
Given IV

Treatment: Drugs: etoposide
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free Survival (EFS)
Timepoint [1] 0 0
At 2 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
At 2 Years
Secondary outcome [1] 0 0
Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Timepoint [1] 0 0
During planned six cycles of chemotherapy
Secondary outcome [2] 0 0
Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)
Timepoint [2] 0 0
At enrollment
Secondary outcome [3] 0 0
Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding
Timepoint [3] 0 0
At enrollment
Secondary outcome [4] 0 0
Pathological Features Present at Diagnosis - Scleral Invasion (SI)
Timepoint [4] 0 0
At enrollment
Secondary outcome [5] 0 0
Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)
Timepoint [5] 0 0
At enrollment
Secondary outcome [6] 0 0
Pathological Features Present At Diagnosis - Iris Infiltration (II)
Timepoint [6] 0 0
At enrollment
Secondary outcome [7] 0 0
Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI)
Timepoint [7] 0 0
At Enrollment

Eligibility
Key inclusion criteria
* 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
* 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
Minimum age
No limit
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2020
Sample size
Target
Accrual to date
Final
331
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Canada
State/province [27] 0 0
Manitoba
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
India
State/province [29] 0 0
Hyderabad
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
New Zealand
State/province [31] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Murali Chintagumpala, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00335738