View Clinical Trial (Medical Research Study)
European Ewing Tumour Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)
| City: |
|
Grand Rapids |
| State: |
|
Michigan |
| Zip Code: |
|
49503 |
| Conditions: |
|
Sarcoma |
| Purpose: |
|
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. Peripheral stem cell transplantation may allow the doctor to give higher doses of
chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is
more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy
regimens to see how well they work when given with or without peripheral stem cell
transplantation, radiation therapy, and/or surgery in treating patients with Ewing's
sarcoma.
|
| Study Summary: |
|
OBJECTIVES:
Primary
- Compare the event-free and overall survival of patients with tumor of the Ewing's
family treated with standard induction chemotherapy comprising vincristine,
dactinomycin, ifosfamide and etoposide (VIDE) followed by consolidation chemotherapy
comprising vincristine, dactinomycin, and ifosfamide versus high-dose busulfan and
melphalan (Bu-Mel) followed by autologous peripheral blood stem cell (PBSC)
transplantation with or without radiotherapy and/or surgery.
Secondary
- Determine the prognostic significance of EWS-Flil transcript in these patients.
- Determine the frequency and prognostic value of minimal disease in bone marrow and
PBSC, as determined by the presence or absence of EWS-Flil transcript, in these
patients.
- Determine the feasibility and toxicity of VIDE induction chemotherapy in these
patients.
- Determine the response of these patients to VIDE induction chemotherapy.
- Determine the feasibility and toxicity of VAI consolodation chemotherapy in these
patients.
- Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these
patients.
- Determine event-free survival and overall survival of patients treated with these
regimens by prognostic group analysis.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
and local treatment of the primary tumor (yes vs no).
Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV
over 3 hours, doxorubicin IV over 4 hours, and etoposide IV over 1 hour on days 1-3 (VIDE).
Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.
Peripheral blood stem cells (PBSC) are collected after course 3 and/or 4. Patients are
evaluated after course 4. Patients in need of early radiotherapy due to an axial tumor or
patients who require radiotherapy to the brain and/or spinal cord (at any time during study)
are assigned to group 1. Patients not needing early radiotherapy are assigned to group 2.
- Group 1: Patients receive 2 additional courses of VIDE induction chemotherapy (courses
5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent
radiotherapy 5 days a week. Some patients may then undergo surgical resection of the
tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and
ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8
courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord
also undergo concurrent radiotherapy.
- Group 2: Patients undergo 2 additional courses of VIDE induction chemotherapy (courses
5 and 6). Some patients may then undergo surgical resection of the tumor. All patients
receive VAI chemotherapy as in group 1 for 1 course. Patients are randomized to 1 of 2
consolidation therapy arms.
- Arm I: Patients receive 7 additional courses of VAI chemotherapy (courses 8-14).
Patients with unresectable, partially resected, or inadequately resected disease
undergo concurrent whole-lung radiotherapy for 6-12 days.
- Arm II: Patients receive high-dose chemotherapy comprising oral busulfan every 6
hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients
receive autologous PBSC IV on day 0. Patients with unresectable, partially
resected, or inadequately resected disease undergo concurrent radiotherapy 5 days
a week for at least 5 weeks.
Patients are followed every 3 months for 4 years, every 6 months for 1 year, and then
periodically thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within
approximately 7 years.
|
| Criteria: |
|
DISEASE CHARACTERISTICS:
- Histologically confirmed tumor of the Ewing's family of bone or soft tissue
- Ewing's sarcoma
- Peripheral primitive neuroectodermal tumor
- Disease meeting one of the following criteria:
- Resectable localized disease (tumor volume less than 200 mL)
- Localized disease previously resected at diagnosis
- Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local
control can be delayed
- Localized disease with early radiotherapy required
- Pulmonary and/or pleural metastases only
- Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)
- No more than 45 days since definitive biopsy
PATIENT CHARACTERISTICS:
Age:
- Under 50
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Renal function normal
- Glomerular filtration rate at least 60 mL/min
Cardiovascular:
- Normal cardiac function
- Fractional shortening at least 29%
- Ejection fraction at least 40%
Other:
- No medical, psychiatric, or social condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
|
| NCT ID: |
|
NCT00020566 |
| Primary Contact: |
|
Study Chair
Alan W. Craft, MD
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Grand Rapids, Michigan 49503
United States
Clinical Trials Office - Helen DeVos Children's Hospital
Phone: 616-391-3050
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 24, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|