Combination Chemotherapy Plus Surgery and Radiation Therapy in Treating Patients With Ewing's Sarcoma

NCT00002516 | Unknown Phase 3

• 6 other identifiers: CDR0000078196GER-GPOH-EICESS-92MRC-EICESS-92EU-92030EU-205116UKCCSG-ET1993-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with surgery and radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with Ewing's sarcoma. PURPOSE: Randomized phase III trial to compare various combination chemotherapy regimens plus surgery and radiation therapy in treating patients who have Ewing's sarcoma.

Conditions

Sarcoma

Keywords

localized Ewing sarcoma/peripheral primitive neuroectodermal tumor; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Interventions

dactinomycin BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

mesna DRUG

vincristine sulfate DRUG

conventional surgery PROCEDURE

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET photon therapy RADIATION

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Biopsy-proven Ewing's sarcoma, atypical Ewing's sarcoma, and peripheral neuroectodermal tumors No soft tissue Ewing's sarcoma or other small cell sarcomas of soft tissue Such patients should be treated on the appropriate national Soft Tissue Sarcoma Protocol Treatment must begin within 3 weeks after diagnostic biopsy Registration must occur within 6 weeks after initiation of treatment PATIENT CHARACTERISTICS: Age: Not over 35 PRIOR CONCURRENT THERAPY: No prior therapy, including primary definitive local therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Muenster: lead
• Medical Research Council: collaborator

Study Sites (1)

Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Related Publications (15)

• Dunst J, Jurgens H, Sauer R, Pape H, Paulussen M, Winkelmann W, Rube C. Radiation therapy in Ewing's sarcoma: an update of the CESS 86 trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):919-30. doi: 10.1016/0360-3016(95)00016-r.

  PMID: 7607966 BACKGROUND

• Nowak-Gottl U, Schaudin E, Hoffmann C, Eckhoff-Donovan S, Mertes N, Winkelmann W, Jurgens H. Intraoperative clotting factor dilution and activated hemostasis in children with Ewing's sarcoma or osteosarcoma: a prospective longitudinal study. Haematologica. 1995 Jul-Aug;80(4):311-7.

  PMID: 7590499 BACKGROUND

• Zoubek A, Dockhorn-Dworniczak B, Delattre O, Christiansen H, Niggli F, Gatterer-Menz I, Smith TL, Jurgens H, Gadner H, Kovar H. Does expression of different EWS chimeric transcripts define clinically distinct risk groups of Ewing tumor patients? J Clin Oncol. 1996 Apr;14(4):1245-51. doi: 10.1200/JCO.1996.14.4.1245.

  PMID: 8648380 BACKGROUND

• Boos J, Krumpelmann S, Schulze-Westhoff P, Euting T, Berthold F, Jurgens H. Steady-state levels and bone marrow toxicity of etoposide in children and infants: does etoposide require age-dependent dose calculation? J Clin Oncol. 1995 Dec;13(12):2954-60. doi: 10.1200/JCO.1995.13.12.2954.

  PMID: 8523060 BACKGROUND

• Dunst J, Jabar S, Paulussen M, Jurgens H. [Local therapy of Ewing sarcoma: radiotherapy aspects]. Klin Padiatr. 1994 Jul-Aug;206(4):277-81. doi: 10.1055/s-2008-1046614. German.

  PMID: 7967424 BACKGROUND

• Hoffmann C, Jabar S, Ahrens S, Rodl R, Rube C, Winkelmann W, Dunst J, Jurgens H. [Prognosis in Ewing sarcoma patients with initial pathological fractures of the primary tumor site]. Klin Padiatr. 1995 Jul-Aug;207(4):151-7. doi: 10.1055/s-2008-1046532. German.

  PMID: 7564145 BACKGROUND

• Nowak-Gottl U, Kehrel B, Budde U, Hoffmann C, Winkelmann W, Jurgens H. Acquired von Willebrand disease in malignant peripheral neuroectodermal tumor (PNET). Med Pediatr Oncol. 1995 Aug;25(2):117-8. doi: 10.1002/mpo.2950250213.

  PMID: 7603396 BACKGROUND

• Ozaki T, Lindner N, Hoffmann C, Hillmann A, Rodl R, Blasius S, Link T, Winkelmann W, Jurgens H. Ewing's sarcoma of the ribs. A report from the cooperative Ewing's sarcoma study. Eur J Cancer. 1995 Dec;31A(13-14):2284-8. doi: 10.1016/0959-8049(95)00522-6.

  PMID: 8652257 BACKGROUND

• Dockhorn-Dworniczak B, Schafer KL, Dantcheva R, Blasius S, Winkelmann W, Strehl S, Burdach S, van Valen F, Jurgens H, Bocker W. Diagnostic value of the molecular genetic detection of the t(11;22) translocation in Ewing's tumours. Virchows Arch. 1994;425(2):107-12. doi: 10.1007/BF00230345.

  PMID: 7524975 BACKGROUND

• Jurgens HF. Ewing's sarcoma and peripheral primitive neuroectodermal tumor. Curr Opin Oncol. 1994 Jul;6(4):391-6.

  PMID: 7803540 BACKGROUND

• Shi LR, Eichelbauer D, Borchard F, Jurgens H, Gobel U, Schneider EM. Specificity and function of monoclonal antibodies directed against Ewing sarcoma cells. Cancer Immunol Immunother. 1994 Mar;38(3):208-13. doi: 10.1007/BF01525643.

  PMID: 8124690 BACKGROUND

• Sari N, Togral G, Cetindag MF, Gungor BS, Ilhan IE. Treatment results of the Ewing sarcoma of bone and prognostic factors. Pediatr Blood Cancer. 2010 Jan;54(1):19-24. doi: 10.1002/pbc.22278.

  PMID: 19760772 RESULT

• Paulussen M, Craft AW, Lewis I, Hackshaw A, Douglas C, Dunst J, Schuck A, Winkelmann W, Kohler G, Poremba C, Zoubek A, Ladenstein R, van den Berg H, Hunold A, Cassoni A, Spooner D, Grimer R, Whelan J, McTiernan A, Jurgens H; European Intergroup Cooperative Ewing's Sarcoma Study-92. Results of the EICESS-92 Study: two randomized trials of Ewing's sarcoma treatment--cyclophosphamide compared with ifosfamide in standard-risk patients and assessment of benefit of etoposide added to standard treatment in high-risk patients. J Clin Oncol. 2008 Sep 20;26(27):4385-93. doi: 10.1200/JCO.2008.16.5720.

  PMID: 18802150 RESULT

• Whelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018.

  PMID: 29610659 RESULT

• Paulussen M, Craft AW, Lewis I, et al.: Ewing tumor of bone - updated report of the European Intergroup Cooperative Ewing's Sarcoma Study EICESS 92. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1568, 2002.

  RESULT

MeSH Terms

Conditions

Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Dactinomycin; Cyclophosphamide; Doxorubicin; Etoposide; Ifosfamide; Mesna; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Heterocyclic Compounds, 1-Ring; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines

Study Officials

• Heribert F. Juergens, MD

  University Hospital Muenster

  STUDY CHAIR

• Alan W. Craft, MD

  Newcastle-upon-Tyne Hospitals NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 5, 2004
• Study Start: July 1, 1992
• Last Updated: September 17, 2013

Record last verified: 2010-01

Locations

GB (1)