NCT00987636: EWING2008

Study in Localized and Disseminated Ewing Sarcoma

Completed Phase 3 Last updated 22 October 2019

What this trial tests

Phase 3 trial testing Zoledronic acid in Ewing's Sarcoma in 907 participants. Completed in 31 March 2019.

Timeline

1 October 2009

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	University Hospital Muenster
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	907
Start date	1 October 2009
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	2 locations across Germany

Drugs / interventions tested

• Zoledronic acid (ZOLEDRONIC ACID) — full drug profile →
• Busulfan — full drug profile →
• Treosulfan (TREOSULFAN) — full drug profile →

Conditions studied

• Ewing's Sarcoma — all drugs for Ewing's Sarcoma →

Sponsor

University Hospital Muenster

Who can join

Adults 48 Months to 50, any sex, with Ewing's Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biology of Bone Sarcomas and New Therapeutic Developments.
   Brown HK, Schiavone K, Gouin F, Heymann MF, et al · · 2018 · cited 116× · PMID 29238848 · DOI 10.1007/s00223-017-0372-2
2. High-Dose Chemotherapy and Blood Autologous Stem-Cell Rescue Compared With Standard Chemotherapy in Localized High-Risk Ewing Sarcoma: Results of Euro-E.W.I.N.G.99 and Ewing-2008.
   Whelan J, Le Deley MC, Dirksen U, Le Teuff G, et al · · 2018 · cited 105× · PMID 30188789 · DOI 10.1200/jco.2018.78.2516
3. High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008.
   Dirksen U, Brennan B, Le Deley MC, Cozic N, et al · · 2019 · cited 93× · PMID 31553693 · DOI 10.1200/jco.19.00915
4. Bone Sarcomas in Pediatrics: Progress in Our Understanding of Tumor Biology and Implications for Therapy.
   Rivera-Valentin RK, Zhu L, Hughes DP. · · 2015 · cited 31× · PMID 26002157 · DOI 10.1007/s40272-015-0134-4
5. Bone Tumor Environment as a Potential Therapeutic Target in Ewing Sarcoma.
   Redini F, Heymann D. · · 2015 · cited 27× · PMID 26779435 · DOI 10.3389/fonc.2015.00279
6. L-MTP-PE and zoledronic acid combination in osteosarcoma: preclinical evidence of positive therapeutic combination for clinical transfer.
   Biteau K, Guiho R, Chatelais M, Taurelle J, et al · · 2016 · cited 26× · PMID 27152244
7. Patterns of care and outcome of CIC-rearranged sarcoma patients: A nationwide study of the French sarcoma group.
   Brahmi M, Gaspar N, Gantzer J, Toulmonde M, et al · · 2023 · cited 20× · PMID 36537582 · DOI 10.1002/cam4.5539
8. Assessment of treatment responses in children and adolescents with Ewing sarcoma with metabolic tumor parameters derived from ¹⁸F-FDG-PET/CT and circulating tumor DNA.
   Schmidkonz C, Krumbholz M, Atzinger A, Cordes M, et al · · 2020 · cited 20× · PMID 31853559 · DOI 10.1007/s00259-019-04649-1