Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Conditions

• Sarcoma

Interventions

BIOLOGICAL

dactinomycin

Given IV

DRUG

busulfan

Given orally and IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

etoposide

Given IV

DRUG

ifosfamide

Given IV

DRUG

melphalan

Given orally and IV

DRUG

vincristine sulfate

Given IV

PROCEDURE

autologous hematopoietic stem cell transplantation

Given IV

PROCEDURE

conventional surgery

Given to patients deemed to require it

RADIATION

radiation therapy

Given to patients deemed to require it

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Cancer and Leukaemia Group

  collaborator OTHER

• Societe Francaise Oncologie Pediatrique

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• German Society for Pediatric Oncology and Hematology GPOH gGmbH

  collaborator OTHER

• Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria

  collaborator OTHER

• Swiss Cancer Institute

  collaborator OTHER

• EBMT Solid Tumors Working Party

  collaborator OTHER

• Children's Oncology Group

  collaborator NETWORK

• University of Leicester

  lead OTHER

Principal Investigators

• Alan W. Craft, MD · Sir James Spence Institute of Child Health at Royal Victoria Infirmary

• Ian J. Lewis, MD · Leeds Cancer Centre at St. James's University Hospital

• Odile Oberlin, MD · Gustave Roussy, Cancer Campus, Grand Paris

• Ian R. Judson, MA, MD, FRCP · Institute of Cancer Research, United Kingdom

• Heribert F. Juergens, MD · University Hospital Muenster

• Helmut Gadner, MD, FRCPG · St. Anna Kinderkrebsforschung

• G. Ulrich Exner, MD · Balgrist Universitaetsklinik

• Ruth Ladenstein, MD · St. Anna Kinderkrebsforschung

• Douglas Hawkins, MD · Seattle Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Max Age

49 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-02-28

Primary Completion

2011-12-31

Countries

• United States
• Australia
• Canada
• New Zealand
• Puerto Rico

Study Locations