Status:
COMPLETED
Study in Localized and Disseminated Ewing Sarcoma
Lead Sponsor:
University Hospital Muenster
Conditions:
Ewing's Sarcoma
Eligibility:
All Genders
48-50 years
Phase:
PHASE3
Brief Summary
Ewing Sarcoma Primary objectives: Standard Risk R1: in a randomised trial, to examine whether add-on treatment with zoledronic acid in addition to induction and maintenance chemotherapy improves eve...
Detailed Description
EWING 2008 is a joint protocol of European and North American Ewing sarcoma study groups. The protocol is aimed at optimising treatment and treatment results of patients with Ewing sarcomas. The EWING...
Eligibility Criteria
Inclusion
- Diagnosis: Histologically confirmed Ewing sarcoma of bone or soft tissue.
- Age and sex: Either sex, age \>48 months (for GPOH patients) and \<50 years at the date of diagnostic biopsy. Younger or elderly patients may be reported to the appropriate office (see section 1.4) but are not included in this study.
- Registration: ≤ 45 days after diagnostic biopsy/surgery.
- Start of chemotherapy: ≤ 45 days after diagnostic biopsy/surgery.
- Informed consent: Must be signed prior to study entry.
- Performance status: Lansky or Karnofsky score \> 50%, may be modified for handicapped patients.
- Haematological parameters:
- Haemoglobin \> 8 g/dl (transfusion allowed),
- Platelets \> 80.000/µl (transfusion allowed),
- WBC \> 2000/µl.
- Cardiac values: LVEF \> 40%, SF \> 28%.
Exclusion
- More than one cycle of other chemotherapy prior to registration
- Second malignancy
- Pregnancy and lactation
- Concurrent treatment within any other clinical trial, except trials with different endpoints that due to the nature of their endpoints must run parallel to EWING 2008 e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc...
- Any other medical, psychiatric, or social condition incompatible with protocol treatment
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
907 Patients enrolled
Trial Details
Trial ID
NCT00987636
Start Date
October 1 2009
End Date
March 31 2019
Last Update
October 22 2019
Active Locations (2)
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1
University Hopital Essen, Pediatrics III, Hematology/ Oncology, Sarcoma Centre, International Ewing Sarcoma Study Group, West German Cancer Centre
Essen, Germany, 45147
2
University Children´s Hospital, Pediatric Hematology and Oncology
Münster, Germany, 48149