The objective of the induction/consolidation chemotherapy randomisation (R1) is to compare: - VIDE strategy: vincristine, ifosfamide, doxorubicin and etoposide (VIDE) as induction chemotherapy and vincristine, actinomycin D and ifosfamide (VAI),…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Event-free survival
Secondary outcome
Overall Survival (OS)
* Adverse events and toxicity, defined by NCI Common Terminology Criteria for
Adverse Events (CTCAE) v4.0
* Histological response of the primary tumour to induction chemotherapy if
surgery is performed as local control
* Response of primary tumour, regional lymfph nodes and/or metastases
* Achievement of local control at the end of treatment
* Growth parameters and jaw/ear osteonecrosis (R2 only)
Background summary
Prof Whelan initiated the trial and brought together a group of renowed sarcoma
specialists in Europe for a FP7 application that supports this academic trial
with the objectives as stated below.
Study objective
The objective of the induction/consolidation chemotherapy randomisation (R1) is
to compare:
- VIDE strategy: vincristine, ifosfamide, doxorubicin and etoposide (VIDE) as
induction chemotherapy and vincristine, actinomycin D and ifosfamide (VAI),
vincristine, actinomycin D /cyclophosphamide (VAI/VAC) or busulfan and
melphalan (BuMel) as consolidation chemotherapy
with
- VDC/IE strategy: alternating cycles of vincristine, cyclophosphamide,
doxorubicin (VDC) and ifosfamide, etoposide (IE) as induction chemotherapy and
alternating cycles of ifosfamide, etoposide (IE) and vincristine,
cyclophosphamide (VC) or busulfan and melphalan (BuMel) as as consolidation
chemotherapy
The objective of the zoledronic acid randomisation (R2) is to determine whether
the addition of zoledronic acid to consolidation chemotherapy, as assigned at
R1, is associated with improved clinical outcome. The objective of the
biological studies associated with this trial is to identify informative
prognostic biomarkers for assessment of disease status and response at
diagnosis and throughout the disease course. Whether they are predictive of
response to therapy and may be used to improve stratification of patients and
whether they might predict those patients that may not tolerate a particular
therapy will be explored.
Study design
The Euro Ewing 2012 trial is an international, phase III, open-label,
randomised controlled trial.
Intervention
2 differrent standard chemoinduction regimens are being compared
postchemo zoldronic acid for 7 cycles are being compared to observation
Study burden and risks
Chemo is standard
Zoledronic acid may give rise to calcium disturbances, or oseonecrosis of the
jaw in rare cases, furthe mild fever or chills after the first cycles
Avenue du Mounier 83/11
Brussel 1200
BE
Avenue du Mounier 83/11
Brussel 1200
BE
Listed location countries
Age
Inclusion criteria
Randomisation 1
- Any histologically and genetically confirmed ESFT of bone or soft tissue, or
round cell sarcomas *Ewing*s-like* but negative for EWSR1 gene rearrangement.
- Age >2 years and <50 years
- Randomisation <=45 days after diagnostic biopsy/surgery
- Patient medically fit to receive the randomised treatment
- No prior treatment other than surgery
Randomisation 2
-Age >5 years
- Localised tumour
OR, -Metastatic disease and/or regional lymph node(s) involvement only at
diagnosis and at least partial response of metastases and/or regional lymph
node(s)
- Consolidation chemotherapy as per protocol intended
-Medically fit to receive zoledronic acid
Exclusion criteria
Randomisation 1
-Contra-indication to the treatment in R1
-Second malignancy
-Pregnant or breast feeding women
Randomisation 2
-History of dental surgery 6 months preceding start of zoledronic acid, or
planned dental surgery during treatment or within 6 months after the end of
treatment.
-Ewing*s tumour of the maxilla or of the mandible
-Progression of the primary tumour or appearance of new lesions
- History of Jaw fracture
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002107-17-NL |
| ISRCTN | ISRCTN92192408 |
| CCMO | NL52900.058.15 |