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

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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.
    

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
    


Study Type

Interventional


Primary Outcome

Outcome data compared to historical controls


Condition

Retinoblastoma

Intervention

carboplatin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

September 2005


Primary Completion Date

July 2010

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

All

Ages

N/A - 15 Years

Accepts Healthy Volunteers

No

Contacts

Helen Jenkinson, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00360750

Organization ID

CDR0000481598

Secondary IDs

CCLG-RB-2005-11


Study Sponsor

Children's Cancer and Leukaemia Group


Study Sponsor

Helen Jenkinson, MD, Study Chair, Birmingham Children's Hospital


Verification Date

June 2009