Clinical trial NCT00360750: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinoblastoma
Keywords: intraocular retinoblastoma
extraocular retinoblastoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-08-07
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Outcome data compared to historical controls
measure: Disease-free and overall survival in children undergoing observation after enucleation
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: England
city: Bristol
country: United Kingdom
facility: Institute of Child Health at University of Bristol
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
state: England
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Sheffield
country: United Kingdom
facility: Children's Hospital - Sheffield
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
Study officials:
affiliation: Birmingham Children's Hospital
name: Helen Jenkinson, MD
role: STUDY_CHAIR
References: