Combination Chemotherapy Plus Surgery and Radiation Therapy in Treating Patients With Ewing's Sarcoma - Full Text View

Sponsors and Collaborators:	Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002516

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Biological: dactinomycin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: mesna Drug: vincristine sulfate Procedure: conventional surgery Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	EUROPEAN INTERGROUP COOPERATIVE EWING'S SARCOMA STUDY [EICESS 92]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy Soft Tissue Sarcoma Surgery

Drug Information available for: Cyclophosphamide Dactinomycin Vincristine Mesna Doxorubicin Doxorubicin hydrochloride Etoposide Myocet Vincristine sulfate Ifosfamide Cobalt

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 1992

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002516

Locations

United Kingdom, England
Royal Victoria Infirmary
Newcastle-upon-Tyne, England, United Kingdom, NE1 4LP

Sponsors and Collaborators

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

Medical Research Council

Investigators

Study Chair:	Heribert F. Juergens, MD	Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
Study Chair:	Alan W. Craft, MD	Newcastle-upon-Tyne Hospitals NHS Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Paulussen M, Craft AW, Lewis I, Hackshaw A, Douglas C, Dunst J, Schuck A, Winkelmann W, Köhler G, Poremba C, Zoubek A, Ladenstein R, van den Berg H, Hunold A, Cassoni A, Spooner D, Grimer R, Whelan J, McTiernan A, Jürgens 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.

Whelan J, McTiernan A, Weston C, et al.: Consequences of different approaches to local treatment of Ewing's sarcoma within an international randomised controlled trial: analysis of EICESS-92. [Abstract] J Clin Oncol 24 (Suppl 18): A-9533, 528s, 2006.

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.

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.

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.

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.

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.

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

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. German.

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.

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.

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.

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

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.

Study ID Numbers:	CDR0000078196, GER-GPOH-EICESS-92, MRC-EICESS-92, EU-92030, EU-205116, UKCCSG-ET1993-02
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002516 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Anti-Infective Agents
Neuroectodermal Tumors, Primitive
Immunologic Factors
Cyclophosphamide
Etoposide phosphate
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Soft Tissue Sarcomas
Sarcoma, Ewing's
Dactinomycin
Cobalt
Neuroepithelioma
Osteogenic Sarcoma
Ewing's Family of Tumors
Alkylating Agents

Etoposide
Osteosarcoma
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Ewing's Sarcoma
Doxorubicin
Neuroectodermal Tumors
Malignant Mesenchymal Tumor
Ifosfamide
Tubulin Modulators
Peripheral Neuroectodermal Tumor
Sarcoma
Antineoplastic Agents, Alkylating
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Sarcoma, Ewing's
Dactinomycin
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type

Mitosis Modulators
Vincristine
Osteosarcoma
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Protein Synthesis Inhibitors
Ifosfamide
Neoplasms
Neoplasms, Bone Tissue
Tubulin Modulators
Myeloablative Agonists
Sarcoma

ClinicalTrials.gov processed this record on September 02, 2009