Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye
A Data Collection Study to Compare the Outcome for Children With Advanced Unilateral Retinoblastoma Treated With or Without Post-Enucleation Chemotherapy ± Radiotherapy on RB 2005 11 With Historical Controls Receiving no Additional Therapy
4 other identifiers
interventional
N/A
1 country
13
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, etoposide, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy with or without radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor does not need more treatment until it progresses. In this case, observation may be sufficient. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
13 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
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 3, 2006
CompletedFirst Posted
Study publicly available on registry
August 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedSeptember 17, 2013
June 1, 2009
4.8 years
August 3, 2006
September 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Outcome data compared to historical controls
Disease-free and overall survival in children undergoing observation after enucleation
Toxicity
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (13)
Birmingham Children's Hospital
Birmingham, England, B4 6NH, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, BS2 8AE, United Kingdom
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester, England, LE1 5WW, United Kingdom
Great Ormond Street Hospital for Children
London, England, WC1N 3JH, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, M27 4HA, United Kingdom
Queen's Medical Centre
Nottingham, England, NG7 2UH, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, S10 2TH, United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Helen Jenkinson, MD
Birmingham Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 3, 2006
First Posted
August 7, 2006
Study Start
September 1, 2005
Primary Completion
July 1, 2010
Last Updated
September 17, 2013
Record last verified: 2009-06