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Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Italian Association for Pediatric Hematology Oncology
Children's Cancer and Leukaemia Group
Dutch Childhood Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00379457
First received: September 19, 2006
Last updated: August 9, 2013
Last verified: July 2009
  Purpose

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
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

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 [ Designated as safety issue: No ]
  • Disease-free survival (in patients treated with maintenance chemotherapy) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Toxicity as measured by NCI-CTC version 3 [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379457

Locations
Austria
St. Anna Children's Hospital Recruiting
Vienna, Austria, A-1090
Contact: Ruth Ladenstein, MD    43-1-404-700      
Belgium
Hopital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Christine Devalck, MD    32-2-477-2678      
Denmark
Rigshospitalet - Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Catherine Rechnitzer, MD, PhD    45-3545-1368    rechnitzer@rh.dk   
Ireland
Our Lady's Hospital for Sick Children Crumlin Recruiting
Dublin, Ireland, 12
Contact: Fin Breatnach, MD, FRCPE    353-1-409-6659    fin.breatnach@olhsc.ie   
Spain
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain, 08035
Contact: Soledad Gallego, MD, PhD    34-93-489-3090    sgallego@vhebron.net   
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-75185
Contact: Gustaf Ljungman, MD    46-18-611-5586      
Switzerland
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    m.stevens@bristol.ac.uk   
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    johannes.visser@uhl-tr.nhs.uk   
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD    44-151-293-3679      
Great Ormond Street Hospital for Children Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Julia Chisholm, MD    44-20-7829-7924      
Middlesex Hospital Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Ananth Shankar, MD    44-20-7380-9300 ext. 9950      
Royal Manchester Children's Hospital Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD    44-161-922-2227    bernadette.brennan@cmmc.nhs.uk   
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    j.p.hale@ncl.ac.uk   
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH    44-115-924-9924 ext. 63394    martin.hewitt@nuh.nhs.uk   
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    mary.gerrard@sch.nhs.uk   
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    anthonymcarthy@royalhospital.n.i.nhs.uk   
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
Investigators
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

Additional Information:
No publications provided

ClinicalTrials.gov 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
Health Authority: Unspecified

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:
Rhabdomyosarcoma
Sarcoma
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Cyclophosphamide
Dactinomycin
Doxorubicin
Liposomal doxorubicin
Topotecan
Vincristine
Vinorelbine
Alkylating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014