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Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma

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ClinicalTrials.gov Identifier: NCT00335738
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Intraocular Retinoblastoma
Interventions: Drug: liposomal vincristine sulfate
Drug: carboplatin
Drug: etoposide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
Group 2 (Identified by Central Review as Not High Risk) Patients undergo observation periodically for at least 5 years.

Participant Flow:   Overall Study
    Group 1 (Identified by Central Review as High Risk)   Group 2 (Identified by Central Review as Not High Risk)
STARTED   108   223 
COMPLETED   97   219 
NOT COMPLETED   11   4 
Physician Decision                6                0 
Withdrawal by Subject                2                0 
Ineligible                3                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 (High Risk)

Patients receive liposomal vincristine sulfate IV aged based dosage (Pts < 36 mos: 0.05 mg/kg, Pts > 36 mos: 1.5 mg/m2, max dose 2 MG) given IV or infusion on day 1, carboplatin aged based dosage (Pts < 36 mos: 18.6 mg/kg Pts > 36 mos: 560 mg/m2) IV on day 1, and Etoposide aged based dosage (Pts < 36 mos: 5 mg/kg, Pts > 36 mos: 150 mg/m2) IV on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

liposomal vincristine sulfate: Given IV

carboplatin: Given IV

etoposide: Given IV

Group 2 (Not High Risk) Patients undergo observation periodically for at least 5 years.
Total Total of all reporting groups

Baseline Measures
   Group 1 (High Risk)   Group 2 (Not High Risk)   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   223   331 
Age 
[Units: Years]
Median (Full Range)
 2 
 (0 to 6) 
 1 
 (0 to 6) 
 2 
 (0 to 6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      52  48.1%      107  48.0%      159  48.0% 
Male      56  51.9%      116  52.0%      172  52.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      24  22.2%      32  14.3%      56  16.9% 
Not Hispanic or Latino      82  75.9%      181  81.2%      263  79.5% 
Unknown or Not Reported      2   1.9%      10   4.5%      12   3.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.9%      0   0.0%      1   0.3% 
Asian      37  34.3%      63  28.3%      100  30.2% 
Native Hawaiian or Other Pacific Islander      1   0.9%      1   0.4%      2   0.6% 
Black or African American      8   7.4%      17   7.6%      25   7.6% 
White      43  39.8%      108  48.4%      151  45.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      18  16.7%      34  15.2%      52  15.7% 
Region of Enrollment 
[Units: Participants]
     
United States   65   144   209 
New Zealand   1   7   8 
India   32   55   87 
Mexico   1   0   1 
Canada   3   7   10 
Australia   6   8   14 
Bangladesh   0   2   2 


  Outcome Measures

1.  Primary:   Event-free Survival (EFS)   [ Time Frame: At 2 years ]

2.  Primary:   Overall Survival (OS)   [ Time Frame: At 2 Years ]

3.  Secondary:   Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: During planned six cycles of chemotherapy ]

4.  Secondary:   Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)   [ Time Frame: At enrollment ]

5.  Secondary:   Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding   [ Time Frame: At enrollment ]

6.  Secondary:   Pathological Features Present at Diagnosis - Scleral Invasion (SI)   [ Time Frame: At enrollment ]

7.  Secondary:   Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)   [ Time Frame: At enrollment ]

8.  Secondary:   Pathological Features Present At Diagnosis - Iris Infiltration (II)   [ Time Frame: At enrollment ]

9.  Secondary:   Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI)   [ Time Frame: At Enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 352-273-0567
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00335738     History of Changes
Other Study ID Numbers: ARET0332
NCI-2009-00423 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000483043 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
COG-ARET0332 ( Other Identifier: Children's Oncology Group )
First Submitted: June 8, 2006
First Posted: June 12, 2006
Results First Submitted: December 2, 2015
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018