| 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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