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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00335738
Ethics application status
Date submitted
8/06/2006
Date registered
12/06/2006
Date last updated
17/04/2018

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) - 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.
Timepoint [1] 0 0
At 2 years
Primary outcome [2] 0 0
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.
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 - Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity.
Timepoint [1] 0 0
During planned six cycles of chemotherapy
Secondary outcome [2] 0 0
Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI) - Proportion of patients who had posterior uveal invasion at enrollment.
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 - Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent.
Timepoint [3] 0 0
At enrollment
Secondary outcome [4] 0 0
Pathological Features Present at Diagnosis - Scleral Invasion (SI) - Proportion of patients that had scleral invasion at enrollment.
Timepoint [4] 0 0
At enrollment
Secondary outcome [5] 0 0
Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS) - Proportion of patients who had anterior chamber seeding at enrollment.
Timepoint [5] 0 0
At enrollment
Secondary outcome [6] 0 0
Pathological Features Present At Diagnosis - Iris Infiltration (II) - Proportion of patients who had iris infiltration at enrollment.
Timepoint [6] 0 0
At enrollment
Secondary outcome [7] 0 0
Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI) - Proportion of patients who had ciliary body infiltration at enrollment.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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 website
https://clinicaltrials.gov/show/NCT00335738
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

Summary results
Other publications