Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye
NCT ID: NCT00360750
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
2005-09-30
Brief Summary
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PURPOSE: This clinical trial is studying how well chemotherapy with or without radiation therapy or observation works in treating young patients with advanced retinoblastoma who have undergone surgery to remove the eye.
Detailed Description
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* Compare outcome data in children with advanced unilateral retinoblastoma with historical controls in order to determine whether post-enucleation chemotherapy with or without radiotherapy improves outcome.
* Determine the disease-free and overall survival of children with unilateral retinoblastoma with no adverse histological features who undergo observation after enucleation.
* Determine the toxicity of these regimens in these patients.
OUTLINE: This is a nonrandomized study. Patients are assigned to 1 of 3 treatment groups according to histological features.
* Group 1 (no adverse histological features): Patients are observed and monitored for the development of orbital recurrence and metastatic disease.
* Group 2a (deep choroidal invasion and/or retrolaminar invasion of the optic nerve and disease in the anterior chamber): Patients receive carboplatin IV over 1 hour, vincristine IV, and etoposide IV over 4 hours on day 1, and, if necessary, intrathecal cytarabine on day 2. Treatment repeats every 21 days for 4 courses.
* Group 2b (invasion of the cut end of the optic nerve): Patients receive carboplatin IV over 1 hour, vincristine IV, and etoposide IV over 4 hours on day 1, and, if necessary, intrathecal cytarabine on day 2. Treatment repeats every 21 days for 6 courses. Patients also undergo orbital radiotherapy 5 days a week for 4 weeks.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: Not specified
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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carboplatin
cytarabine
etoposide
vincristine sulfate
clinical observation
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed unilateral retinoblastoma
* Prior primary enucleation required
* No metastatic spread
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy
* No concurrent steroids as antiemetic agents
15 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Helen Jenkinson, MD
Role: STUDY_CHAIR
Birmingham Children's Hospital
Locations
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Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CCLG-RB-2005-11
Identifier Type: -
Identifier Source: secondary_id
EU-20616
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2004-001367-21
Identifier Type: -
Identifier Source: secondary_id
CDR0000481598
Identifier Type: -
Identifier Source: org_study_id