Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CCLG-RB-2005-11 | |||
| EU-20616 | |||
| EUDRACT-2004-001367-21 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
OUTLINE: This is a nonrandomized study. Patients are assigned to 1 of 3 treatment groups according to histological features.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: Not specified
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| cytarabine | Drug | |||
| etoposide | Drug | |||
| vincristine sulfate | Drug | |||
| clinical observation | Other | |||
| adjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome data compared to historical controls | ||
| Disease-free and overall survival in children undergoing observation after enucleation | ||
| Toxicity |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed unilateral retinoblastoma
No metastatic spread
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helen Jenkinson, MD | Birmingham Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Children's Hospital | Birmingham | England | B4 6NH | United Kingdom | ||
| Institute of Child Health at University of Bristol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D012175 | Retinoblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| D014750 | Vincristine |
| D057832 | Watchful Waiting |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided