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Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379457
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : September 21, 2006
Last Update Posted : August 12, 2013
Italian Association for Pediatric Hematology Oncology
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with nonmetastatic rhabdomyosarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Biological: dactinomycin Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: topotecan hydrochloride Drug: vincristine sulfate Drug: vinorelbine tartrate Procedure: conventional surgery Radiation: radiation therapy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Protocol For Nonmetastatic Rhabdomyosarcoma [RMS-2005]
Study Start Date : June 2006
Estimated Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Event-free survival
  2. Disease-free survival (in patients treated with maintenance chemotherapy)

Secondary Outcome Measures :
  1. Overall survival
  2. Progression-free survival
  3. Response rate
  4. Toxicity as measured by NCI-CTC version 3

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed rhabdomyosarcoma (RMS) or other malignant mesenchymal tumor, including undifferentiated soft tissue sarcoma or ectomesenchymoma

    • Has undergone diagnostic surgery within the past 8 weeks
  • Meets criteria for 1 of the following risk groups:

    • Low-risk group

      • Localized nonalveolar RMS at any site
      • Embryonal, spindle cell, or botryoid RMS (favorable pathology)
      • Microscopically completely resected disease (Intergroup Rhabdomyosarcoma Study [IRS] group I)
      • Negative nodes (N0)
      • Tumor size ≤ 5 cm AND age < 10 years (favorable tumor size and age)
    • Standard-risk group, meeting criteria for 1 of the following subgroups:

      • Subgroup B

        • Localized nonalveolar RMS at any site
        • Favorable pathology
        • Microscopically completely resected disease (IRS group I)
        • N0 disease
        • Tumor size > 5 cm OR age ≥ 10 years (unfavorable tumor size or age)
      • Subgroup C

        • Localized nonalveolar RMS in orbit, head and neck nonparameningeal sites, or genitourinary (GU) non bladder prostate (i.e., paratesticular and vagina/uterus) sites (favorable site)
        • Favorable pathology
        • Microscopic residual disease (pT3a) or completely resected disease with nodal involvement (N1) (IRS group II) OR macroscopic residual disease (pT3b) (IRS group III)
        • N0 disease
        • Any tumor size or age
      • Subgroup D

        • Localized nonalveolar RMS in parameningeal sites, extremities, GU bladder prostate sites, or other sites (unfavorable site)
        • Favorable pathology
        • IRS group II or III
        • N0 disease
        • Favorable tumor size and age
    • High-risk group, meeting criteria for 1 of the following subgroups:

      • Subgroup E

        • Localized nonalveolar RMS at unfavorable site
        • Favorable pathology
        • IRS group II or III
        • N0 disease
        • Unfavorable tumor size or age
      • Subgroup F

        • Localized nonalveolar RMS at any site
        • Favorable pathology
        • IRS group I, II, or III
        • Positive nodes (N1)
        • Any tumor size or age
      • Subgroup G

        • Localized alveolar RMS at any site
        • Alveolar RMS, including the solid-alveolar variant (unfavorable pathology)
        • IRS group I, II, or III
        • N0 disease
        • Any tumor size or age
    • Very high-risk group

      • Localized alveolar RMS at any site
      • Unfavorable pathology
      • IRS group I, II, or III
      • N1 disease
      • Any tumor size or age
  • Previously untreated disease (except for primary surgery)
  • No evidence of metastatic disease


  • Shortening fraction > 28%
  • Ejection fraction > 47%
  • No prior cardiac disease
  • Renal function must be equivalent to grade 0-1 nephrotoxicity
  • No prior malignant tumors
  • No pre-existing illness preventing treatment


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379457

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St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Ruth Ladenstein, MD    43-1-404-700      
Hopital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Christine Devalck, MD    32-2-477-2678      
Rigshospitalet - Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Catherine Rechnitzer, MD, PhD    45-3545-1368   
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Fin Breatnach, MD, FRCPE    353-1-409-6659   
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain, 08035
Contact: Soledad Gallego, MD, PhD    34-93-489-3090   
Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-75185
Contact: Gustaf Ljungman, MD    46-18-611-5586      
University Children's Hospital Recruiting
Zurich, Switzerland, CH-8032
Contact: Felix Niggli, MD    41-44-266-7823      
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, England, United Kingdom, B16 8ET
Contact: David Hobin, MD    44-121-454-4851      
Institute of Child Health at University of Bristol Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: M. C. G. Stevens, MD    44-117-342-0205   
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Denise Williams, MD    44-1223-256-298      
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Martin Elliott, MD    44-113-206-4988      
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Johann Visser, MD    44-116-258-5309   
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD    44-151-293-3679      
Middlesex Hospital Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Ananth Shankar, MD    44-20-7380-9300 ext. 9950      
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Julia Chisholm, MD    44-20-7829-7924      
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD    44-161-922-2227   
Sir James Spence Institute of Child Health at Royal Victoria Infirmary Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Juliet Hale, MD    44-191-282-4101   
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH    44-115-924-9924 ext. 63394   
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Sheila Lane, MD    44-1865-234-205      
Children's Hospital - Sheffield Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH    44-114-271-7366   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP    44-23-8079-6942      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Kathy Pritchard-Jones, MD    44-20-8661-3452 ext 3498      
Royal Belfast Hospital for Sick Children Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Contact: Anthony McCarthy, MD    44-289-063-3631   
Royal Aberdeen Children's Hospital Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Contact: Derek King, MD    44-1224-681-818      
Royal Hospital for Sick Children Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD    44-141-201-9309      
Childrens Hospital for Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Meriel Jenney, MD    44-292-074-2107      
Sponsors and Collaborators
European Paediatric Soft Tissue Sarcoma Study Group
Italian Association for Pediatric Hematology Oncology
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
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Study Chair: Gianni Bisogno, MD Azienda Ospedaliera di Padova
Study Chair: Meriel Jenney, MD Childrens Hospital for Wales
Study Chair: Hans Merks, MD, PhD Dutch Childhood Oncology Group

Layout table for additonal information Identifier: NCT00379457     History of Changes
Other Study ID Numbers: CCLG-EPSSG-RMS-2005
CDR0000508635 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
alveolar childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
childhood malignant mesenchymoma
nonmetastatic childhood soft tissue sarcoma
embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators