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Study in Localized and Disseminated Ewing Sarcoma

NCT00987636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 907

Last updated 2019-10-22

No results posted yet for this study

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 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.

Conditions

  • Ewing's Sarcoma

Interventions

DRUG

Zoledronic acid

intravenously at 28 day intervals beginning with cycle 6 of VAC/VAI consolidation chemotherapy for a total period of nine months. Patients \< 18 years will receive 0.05 mg/kg BW by IV infusion 30 min-1 h. Patients \>= 18 years will receive a bodyweight-dependent dose: Patients \>40kg receive 4 mg by IV infusion 30 min-1h Patients 20-40 kg receive 2 mg by IV infusion 30 min-1h

DRUG

Busulfan

intravenously, day -6 to d -3 adults: 0.8 mg/kg body weight (BW) children and adolescents: \<9 kg= 1mg/kg BW 9 - \<16 kg= 1.2 mg/kg BW 16 - 23 kg= 1.1 mg/kg BW \>23 - 34 kg= 0.95 mg/kg BW \>34 kg = 0.8 mg/kg BW

DRUG

Treosulfan

12 g/m² d-5 to d-3

Sponsors & Collaborators

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Uta Dirksen, Prof MD · University Hospital, Essen

  • Alan W Craft, Prof Sir MD · Royal Victoria Infirmary

  • Heribert Jürgens, Prof MD · University Hospital Muenster

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Months
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-01
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987636 on ClinicalTrials.gov