Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

NCT00379457 | Unknown Phase 3

• 5 other identifiers: CCLG-EPSSG-RMS-2005CDR0000508635EU-20639EUDRACT-2005-000217-35UKCCSG-RMS-2005
• Study Type: interventional
• Target: 600
• Locations: 8 countries
• Sites: 27

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.

Conditions

Sarcoma

Keywords

alveolar childhood rhabdomyosarcoma; previously untreated childhood rhabdomyosarcoma; childhood malignant mesenchymoma; nonmetastatic childhood soft tissue sarcoma; embryonal childhood rhabdomyosarcoma; embryonal-botryoid childhood rhabdomyosarcoma

Outcome Measures

Primary Outcomes (2)

• Event-free survival

• Disease-free survival (in patients treated with maintenance chemotherapy)

Secondary Outcomes (4)

• Overall survival

• Progression-free survival

• Response rate

• Toxicity as measured by NCI-CTC version 3

Interventions

dactinomycin BIOLOGICAL

carboplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

topotecan hydrochloride DRUG

vincristine sulfate DRUG

vinorelbine tartrate DRUG

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Paediatric Soft Tissue Sarcoma Study Group: lead
• Italian Association for Pediatric Hematology Oncology: collaborator
• Children's Cancer and Leukaemia Group: collaborator
• Dutch Childhood Oncology Group: collaborator

Study Sites (27)

St. Anna Children's Hospital

Vienna, A-1090, Austria

RECRUITING

Hopital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

Uppsala University Hospital

Uppsala, SE-75185, Sweden

RECRUITING

University Children's Hospital

Zurich, CH-8032, Switzerland

RECRUITING

Birmingham Children's Hospital

Birmingham, England, B16 8ET, United Kingdom

RECRUITING

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

RECRUITING

Middlesex Hospital

London, England, W1T 3AA, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

RECRUITING

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

RECRUITING

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

RECRUITING

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

RECRUITING

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

RECRUITING

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

RECRUITING

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

RECRUITING

Related Publications (2)

• Orbach D, Van Noesel MM, Brennan B, Corradini N, Alaggio R, Ben Arush M, Schoot RA, Berlanga P, Zanetti I, Hjalgrim LL, Di Corti F, Ramirez G, Casanova M, Ferrari A. Epithelioid hemangioendothelioma in children: The European Pediatric Soft Tissue Sarcoma Study Group experience. Pediatr Blood Cancer. 2022 Oct;69(10):e29882. doi: 10.1002/pbc.29882. Epub 2022 Jul 16.

  PMID: 35841307 DERIVED

• Schoot RA, Chisholm JC, Casanova M, Minard-Colin V, Geoerger B, Cameron AL, Coppadoro B, Zanetti I, Orbach D, Kelsey A, Rogers T, Guizani C, Elze M, Ben-Arush M, McHugh K, van Rijn RR, Ferman S, Gallego S, Ferrari A, Jenney M, Bisogno G, Merks JHM. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. J Clin Oncol. 2022 Nov 10;40(32):3730-3740. doi: 10.1200/JCO.21.02981. Epub 2022 Jun 16.

  PMID: 35709412 DERIVED

MeSH Terms

Conditions

Sarcoma; Malignant mesenchymal tumor

Interventions

Dactinomycin; Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Ifosfamide; Topotecan; Vincristine; Vinorelbine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2009-07

Locations

GB (20); CH (1); DK (1); BE (1); IE (1); ES (1); AU (1); SE (1)