Combination Chemotherapy Followed by Radiation Therapy in Treating Children... | Completed
Combination Chemotherapy Followed b... | Completed
Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma

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Medical Conditions
  • Brain and Central Nervous System Tumors
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT00004224

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Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.
Research Details
  • OBJECTIVES:

    - Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy.

    - Determine the response rate in these patients to this regimen.

    OUTLINE: This is a multicenter study.

    Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy.

    Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended.

    Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery.

    Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

    PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.
Phase
Phase 2
Study Design
Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : cyclophosphamide, Drug : etoposide, Drug : vincristine sulfate, Procedure : adjuvant therapy, Procedure : conventional surgery, Radiation : radiation therapy

Study Arm Groups : , , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
    Event-free survival; null; Overall survival; null; Surgical operability; null; Response rate; null
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
3 Years - 20 Years
Who Can Participate
Patients
Number of Participants
65
Participant Inclusion Criteria
    DISEASE CHARACTERISTICS:

    - Histologically proven nonmetastatic intracranial ependymoma

    - Cellular

    - Papillary

    - Clear cell

    - Mixed cell

    - Anaplastic

    - No myxopapillary ependymoma, subependymoma, or ependymoblastoma

    PATIENT CHARACTERISTICS:

    Age:

    - 3 to 20

    Performance status:

    - Not specified

    Life expectancy:

    - Not specified

    Hematopoietic:

    - No hematologic disease that would preclude study participation

    Hepatic:

    - Not specified

    Renal:

    - No renal disease that would preclude study participation

    Other:

    - No concurrent unrelated disease that would preclude study participation

    PRIOR CONCURRENT THERAPY:

    Biologic therapy:

    - Not specified

    Chemotherapy:

    - No prior chemotherapy

    Endocrine therapy:

    - Prior steroids allowed

    Radiotherapy:

    - No prior radiotherapy

    Surgery:

    - Not specified
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Birmingham
B4 6NH
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Canada, Italy, Netherlands, Spain, Sweden, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
SIOP Study of Combined Modality Treatment in Childhood Ependymoma
EudraCT Number
Not available for this trial
Funder(s)
  • Children's Cancer and Leukaemia Group
  • Italian Association for Pediatric Hematology Oncology
Other Study ID Numbers
CDR0000067465
Sponsor(s)
Societe Internationale d'Oncologie Pediatrique
Key Dates

Recruitment Start Date

Jan 1999

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

28 Jan 2000

Date updated in source

23 Aug 2013