Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Italian Association for Pediatric Hematology Oncology
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 19, 2006
Last updated: August 9, 2013
Last verified: July 2009

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 Intervention Phase
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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Protocol For Nonmetastatic Rhabdomyosarcoma [RMS-2005]

Resource links provided by NLM:

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

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

Secondary Outcome Measures:
  • Overall survival
  • Progression-free survival
  • Response rate
  • Toxicity as measured by NCI-CTC version 3

Estimated Enrollment: 600
Study Start Date: June 2006
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00379457

St. Anna Children's Hospital
Vienna, Austria, A-1090
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium, 1020
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, 2100
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Uppsala University Hospital
Uppsala, Sweden, SE-75185
University Children's Hospital
Zurich, Switzerland, CH-8032
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B16 8ET
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
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
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
  More Information Identifier: NCT00379457     History of Changes
Other Study ID Numbers: CCLG-EPSSG-RMS-2005  CDR0000508635  EU-20639  EUDRACT-2005-000217-35  UKCCSG-RMS-2005 
Study First Received: September 19, 2006
Last Updated: August 9, 2013

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:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents processed this record on January 23, 2017