Chemotherapy With or Without Radiation Therapy or Observation in Treating Young Patients With Advanced Retinoblastoma Who Have Undergone Surgery to Remove the Eye

Retinoblastoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00360750
• Other study ID #: CDR0000481598
• Secondary ID: CCLG-RB-2005-11E
• Status: Active, not recruiting
• Phase: N/A
• First received: August 3, 2006
• Last updated: September 16, 2013
• Start date: September 2005

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• carboplatin

• cytarabine

• etoposide

• vincristine sulfate

Other:
• clinical observation

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Institute of Child Health at University of Bristol	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Great Ormond Street Hospital for Children	London	England
United Kingdom	Royal Manchester Children's Hospital	Manchester	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Children's Hospital - Sheffield	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome data compared to historical controls			No
Primary	Disease-free and overall survival in children undergoing observation after enucleation			No
Primary	Toxicity			Yes