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Clinical Trial Name - Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Adva

 
Original Study ID : CDR0000481598
Secondary ID : Array
NCT ID : NCT00360750
Brief Title : Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye
Official Title : 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
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.

Source : National Cancer Institute (NCI)
Detailed Description :

OBJECTIVES: - 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

Overall Status : Recruiting
Start Date : September 2005
Official Title : N/A
Phase : Interventional
Study Design : Treatment, Non-Randomized, Open Label
Verification Date : April 2008
First Received Date : August 3, 2006
Trial Eligibility
Criteria :
DISEASE CHARACTERISTICS:

- 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
Gender : Both
Minimum Age : N/A
Maximum Age : 15 Years
Healthy Volunteers : No
Facilities
Facility Name : Our Lady's Hospital for Sick Children Crumlin
Status : Recruiting
City : Dublin
Zip Code : 12
Country : Ireland
Facility Name : Addenbrooke's Hospital
Status : Recruiting
City : Cambridge
State : England
Zip Code : CB2 2QQ
Country : United Kingdom
Facility Name : Birmingham Children's Hospital
Status : Recruiting
City : Birmingham
State : England
Zip Code : B4 6NH
Country : United Kingdom
Facility Name : Children's Hospital - Sheffield
Status : Recruiting
City : Sheffield
State : England
Zip Code : S10 2TH
Country : United Kingdom
Facility Name : Great Ormond Street Hospital for Children
Status : Recruiting
City : London
State : England
Zip Code : WC1N 3JH
Country : United Kingdom
Facility Name : Institute of Child Health at University of Bristol
Status : Recruiting
City : Bristol
State : England
Zip Code : BS2 8AE
Country : United Kingdom
Facility Name : Leeds Cancer Centre at St. James's University Hospital
Status : Recruiting
City : Leeds
State : England
Zip Code : LS9 7TF
Country : United Kingdom
Facility Name : Leicester Royal Infirmary
Status : Recruiting
City : Leicester
State : England
Zip Code : LE1 5WW
Country : United Kingdom
Facility Name : Middlesex Hospital
Status : Recruiting
City : London
State : England
Zip Code : W1T 3AA
Country : United Kingdom
Facility Name : Oxford Radcliffe Hospital
Status : Recruiting
City : Oxford
State : England
Zip Code : 0X3 9DU
Country : United Kingdom
Facility Name : Queen's Medical Centre
Status : Recruiting
City : Nottingham
State : England
Zip Code : NG7 2UH
Country : United Kingdom
Facility Name : Royal Liverpool Children's Hospital, Alder Hey
Status : Recruiting
City : Liverpool
State : England
Zip Code : L12 2AP
Country : United Kingdom
Facility Name : Royal Manchester Children's Hospital
Status : Recruiting
City : Manchester
State : England
Zip Code : M27 4HA
Country : United Kingdom
Facility Name : Royal Marsden - Surrey
Status : Recruiting
City : Sutton
State : England
Zip Code : SM2 5PT
Country : United Kingdom
Facility Name : Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Status : Recruiting
City : Newcastle-Upon-Tyne
State : England
Zip Code : NE1 4LP
Country : United Kingdom
Facility Name : Southampton General Hospital
Status : Recruiting
City : Southampton
State : England
Zip Code : SO16 6YD
Country : United Kingdom
Facility Name : Royal Belfast Hospital for Sick Children
Status : Recruiting
City : Belfast
State : Northern Ireland
Zip Code : BT12 6BE
Country : United Kingdom
Facility Name : Royal Aberdeen Children's Hospital
Status : Recruiting
City : Aberdeen
State : Scotland
Zip Code : AB25 2ZG
Country : United Kingdom
Facility Name : Royal Hospital for Sick Children
Status : Recruiting
City : Glasgow
State : Scotland
Zip Code : G3 8SJ
Country : United Kingdom
Facility Name : Royal Hospital for Sick Children
Status : Recruiting
City : Edinburgh
State : Scotland
Zip Code : EH9 1LF
Country : United Kingdom
Facility Name : Childrens Hospital for Wales
Status : Recruiting
City : Cardiff
State : Wales
Zip Code : CF14 4XW
Country : United Kingdom
OutComes
Primary OutComes
Interventions
Type : Drug
Name : carboplatin
Type : Drug
Name : cytarabine
Type : Drug
Name : etoposide
Type : Drug
Name : vincristine sulfate
Type : Procedure
Name : adjuvant therapy
Type : Procedure
Name : observation
Type : Radiation
Name : radiation therapy
 
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