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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.
 
ClinicalTrials.gov 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
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)

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

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00379457


Locations
Show Show 27 study locations
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
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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

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ClinicalTrials.gov Identifier: NCT00379457    
Other Study ID Numbers: CCLG-EPSSG-RMS-2005
CDR0000508635 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20639
EUDRACT-2005-000217-35
UKCCSG-RMS-2005
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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Sarcoma
Rhabdomyosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Dactinomycin
Cyclophosphamide
Ifosfamide
Doxorubicin
Etoposide
Vincristine
Vinorelbine
Topotecan
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