EWING 2008 : Phase 3, Open Label, Multi-centre, Randomised Controlled International Study in Ewing Sarcoma (Other ID's:108128, EudraCT number: 2008-003658-13)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

2-50Age 2-50

Sarcoma<br/>CancersCancer LocationSarcoma
Cancers

Systemic therapy | SarcomaEwing's Sarcoma,

Trial Overview Read MoreRead more

This phase III trial is trying to assess whether the addition of three different drugs, to prescribed chemotherapy treatment, will improve survival outcomes for people with Ewing's Sarcoma.
 

This trial is treating patients with Ewing's Sarcoma (bone or soft tissue).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Phase 3, Open Label, Multi-centre, Randomised Controlled International Study in Ewing Sarcoma (Other ID's:108128, EudraCT number: 2008-003658-13)

Other Non-Commercial Sponsor

University Hospital Muenster

Summary

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 2008 protocol is open to all patients diagnosed with Ewing sarcomas, localised or metastatic, who are considered eligible for neoadjuvant chemotherapy. All patients registered will receive induction chemotherapy consisting of six cycles of vincristine, ifosfamide, doxorubicin and etoposide (VIDE). The decision regarding local therapy must be made following the fifth cycle of induction treatment, with a preference for surgical intervention with or without additional radiotherapy. Preoperative radiotherapy may be considered to improve the operability of otherwise inoperable lesions. In patients with localised disease or with pulmonary metastases, local treatment should be performed following the 6th cycle of VIDE chemotherapy, and should be a complete tumour resection, whenever feasible. Post-operative radiotherapy is determined by the completeness of surgery and the histological response to chemotherapy. Standard Risk R1 Good responders (R1) (< 10%="" viable="" tumour="" cells)="" with="" localised="" disease="" are="" allocated="" to="" the="" standard="" risk="" arm="" and="" will="" receive="" a="" further="" eight="" cycles="" of="" chemotherapy="" composed="" of="" vincristine,="" actinomycin="" d,="" and="" cyclophosphamide="" (vac)="" (females)="" or="" ifosfamide="" instead="" of="" cyclophosphamide="" (vai)="" (males).="" they="" will="" be="" randomised="" to="" receive="" add-on="" treatment="" with="" either="" fenretinide,="" zoledronic="" acid,="" fenretinide="" plus="" zoledronic="" acid,="" or="" no="" add-on="" treatment.="" high="" risk="" r2="" poor="" responders="" (r2)="" with="" localised="" disease="" will="" continue="" to="" be="" randomised="" as="" in="" euro-e.w.i.n.g.="" 99="" to="" receive="" either="" eight="" cycles="" of="" vai="" chemotherapy="" or="" high="" dose="" treatment="" with="" busulfan-melphalan="" (r2loc).="" patients="" with="" primary="" pulmonary="" metastases="" are="" also="" allocated="" to="" continue="" to="" be="" randomised="" as="" in="" euro-e.w.i.n.g.="" 99="" to="" receive="" either="" eight="" cycles="" of="" vai="" chemotherapy="" or="" high="" dose="" treatment="" with="" busulfan-melphalan="" (r2pulm).="" very="" high="" risk="" r3="" patients="" with="" disseminated="" disease,="" i.e.="" dissemination="" to="" bone="" and/or="" other="" sites="" and="" possibly="" additional="" pulmonary="" dissemination="" (r3),="" receive="" six="" cycles="" of="" vide="" induction="" chemotherapy.="" patients="" are="" then="" randomised="" to="" either="" continue="" with="" eight="" cycles="" of="" vincristine,="" actinomycin="" d="" and="" cyclophosphamide="" (vac)="" chemotherapy="" or="" high="" dose="" treosulfan-melphalan="" (treomel)="" chemotherapy="" followed="" by="" autologous="" stem="" cell="" reinfusion="" followed="" thereafter="" by="" eight="" cycles="" of="" vac="" chemotherapy.="" local="" therapy="" in="" r3="" patients="" is="" following="" vide="" induction,="" whenever="" feasible="" prior="" to="" high="" dose="" therapy="" (hdt).="" when="" long="" periods="" of="" immobilisation="" following="" surgery="" are="" anticipated,="" e.g="" pelvic="" reconstruction,="" surgery="" following="" hdt="" may="" be="" advisable.="" depending="" on="" clinical="" response="" to="" induction="" chemotherapy="" radiotherapy="" prior="" to="" hdt="" and="" surgery="" may="" be="" an="" option="" to="" be="" considered="" in="" such="" patients.="" any="" delay="" between="" vide="" and="" hdt="" for="" reasons="" of="" e.g.="" local="" treatment="" must="" be="" bridged="" with="" vac="" cycles.="" the="" total="" number="" of="" vac="" cycles="" is="" not="" to="" exceed="" eight="" cycles.="">

Recruiting Hospitals Read MoreRead more

Monash Children's Cancer Centre
Clayton
Ms Sema Cakan
sema.cakan@monashhealth.org
(03) 9594 7660

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Royal Childrens Hospital
Parkville
Ms Allison Lamb
allison.lamb@rch.org.au
(03) 9345 4989