Ewing's Sarcoma Clinical Trial
— EWING2008Official title:
Phase 3, Open Label, Multi-centre, Randomised Controlled International Study in Ewing Sarcoma
Verified date | October 2019 |
Source | University Hospital Muenster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 event-free survival in
patients with localised Ewing sarcoma and good histological response or with initial tumour
volume <200 mL compared to no add-on treatment.
*High Risk R2: in a randomised trial, to examine whether high-dose chemotherapy using
busulfan-melphalan with autologous stem cell reinfusion, compared with standard chemotherapy,
improves event-free survival in patients with localised Ewing sarcoma and poor histological
response or tumour volume ≥200 mL (R2loc). In patients with pulmonary metastases high dose
busulfan-melphalan chemotherapy with autologous stem cell reinfusion is randomised versus
standard chemotherapy plus whole lung irradiation (R2pulm).
Very High Risk R3: in a randomised trial, to examine whether the addition of high dose
chemotherapy using treosulfan-melphalan followed by autologous stem cell reinfusion to eight
cycles of standard adjuvant chemotherapy, compared to eight cycles of standard adjuvant
chemotherapy alone, improves event-free survival in patients with primary disseminated
disease.
*R2 accrual discontinued on December 1st 2015.
Status | Completed |
Enrollment | 907 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 48 Months to 50 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hopital Essen, Pediatrics III, Hematology/ Oncology, Sarcoma Centre, International Ewing Sarcoma Study Group, West German Cancer Centre | Essen | |
Germany | University Children´s Hospital, Pediatric Hematology and Oncology | Muenster |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event free survival | 9.5 years | ||
Secondary | Overall survival | 9.5 years | ||
Secondary | Safety and toxicity | permanent | ||
Secondary | Quality of life | 9.5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01734863 -
Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
|
Phase 3 | |
Completed |
NCT01674101 -
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy
|
N/A | |
Completed |
NCT02736565 -
Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma
|
Phase 1 | |
Completed |
NCT00563680 -
QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors
|
Phase 2 | |
Terminated |
NCT00038142 -
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients
|
Phase 2 | |
Completed |
NCT02890758 -
Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803
|
Phase 1 | |
Completed |
NCT01583543 -
Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma
|
Phase 2 | |
Terminated |
NCT01313884 -
Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
|
Phase 2 | |
Completed |
NCT01696669 -
Study of Intensive Chemotherapy, Surgery and Radiotherapy to Treat Ewing's Sarcoma in Children and Young Adults
|
Phase 2 | |
Completed |
NCT00004853 -
Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts After Intensive Chemotherapy
|
Phase 1 | |
Terminated |
NCT00568464 -
Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)
|
Phase 2 | |
Completed |
NCT00001686 -
Evaluation, Treatment, and Natural History of Children and Young Adults With Cancer or Rare Diseases
|
||
Completed |
NCT00492141 -
Aerosol L9-NC and Temozolomide in Ewing's Sarcoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00541411 -
Phase II Pilot Study of Vincristine, Adriamycin, Actinomycin D, Ifosfamide Combination Chemotherapy in Ewing's Sarcoma
|
N/A | |
Completed |
NCT02063022 -
Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma
|
Phase 3 | |
Completed |
NCT01598454 -
Use of Racotumomab in Patients With Pediatric Tumors Expressing N-glycolylated Gangliosides
|
Phase 1 | |
Recruiting |
NCT03442465 -
Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas
|
||
Completed |
NCT02511132 -
A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
|
Phase 2 | |
Completed |
NCT00923650 -
Informed Consent in Pediatric Cancer Trials
|
N/A | |
Completed |
NCT01962103 -
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors
|
Phase 1/Phase 2 |