Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma

NCT00334854 | Unknown Phase 3

• 6 other identifiers: CCLG-EPSSG-NRSTS-2005CDR0000482277EU-20620EUDRACT-2005-001139-31UKCCSG-CTA-21275/0215/001/0001CCLG-EpSSG-STS-2006-03
• Study Type: interventional
• Target: 250
• Locations: 9 countries
• Sites: 28

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin, radiation therapy, and/or surgery works in treating young patients with localized soft tissue sarcoma.

Conditions

Childhood Malignant Fibrous Histiocytoma of Bone; Sarcoma

Keywords

childhood synovial sarcoma; nonmetastatic childhood soft tissue sarcoma; childhood alveolar soft-part sarcoma; childhood angiosarcoma; childhood epithelioid sarcoma; childhood fibrosarcoma; childhood leiomyosarcoma; childhood liposarcoma; childhood neurofibrosarcoma; localized childhood malignant fibrous histiocytoma of bone; childhood malignant hemangiopericytoma; dermatofibrosarcoma protuberans; chondrosarcoma

Outcome Measures

Primary Outcomes (5)

• Event-free survival

• Local relapse-free survival

• Metastases-free survival

• Overall survival

• Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)

Interventions

doxorubicin hydrochloride DRUG

ifosfamide DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy 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 synovial sarcoma or adult-type soft-tissue sarcoma * Adult-type soft tissue sarcoma includes any of the following: * Fibrosarcoma (adult-type) * No infantile fibrosarcoma * Malignant peripheral nerve sheath tumor * Malignant schwannoma * Neurofibrosarcoma * Epithelioid sarcoma * Leiomyosarcoma * Clear cell sarcoma * Liposarcoma * Alveolar soft-part sarcoma * Malignant fibrous histiocytoma * Hemangiopericytoma * Angiosarcoma * Dermatofibrosarcoma protuberans * Mesenchymal chondrosarcoma * No borderline tumors (e.g., hemangioendothelioma) * No small round cell tumors (e.g., extraosseous Ewing's sarcoma/primitive neuroectodermal tumor or desmoplastic small round cell tumor) * Post-irradiation soft-part sarcomas allowed * Diagnostic surgery performed within the past 8 weeks (for patients who require adjuvant chemotherapy) * No evidence of metastatic disease * Involved locoregional lymph nodes are allowed PATIENT CHARACTERISTICS: * No prior malignancy * No pre-existing illness precluding study treatment\* * Normal renal function (nephrotoxicity grade 0-1)\* * No history of cardiac disease\* * Normal shortening fraction (\> 28%)\* * Ejection fraction \> 47%\* NOTE: \* For patients who require adjuvant chemotherapy PRIOR CONCURRENT THERAPY: * No prior cancer treatment except primary surgery

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
• Cooperative Weichteilsarkom Studie: collaborator
• Children's Cancer and Leukaemia Group: collaborator
• Dutch Childhood Oncology Group: collaborator

Study Sites (28)

St. Anna Children's Hospital

Vienna, A-1090, Austria

RECRUITING

Clinique de l'Esperance

Montegnée, 4420, Belgium

RECRUITING

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

Institut Curie Hopital

Paris, 75248, France

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

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma; Fibrosarcoma; Liposarcoma; Hemangiopericytoma, Malignant; Dermatofibrosarcoma; Chondrosarcoma

Interventions

Doxorubicin; Ifosfamide; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Andrea Ferrari, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY CHAIR

• Modesto Carli, MD

  Azienda Ospedaliera di Padova

  STUDY CHAIR

• Joern Treuner, MD

  Olgahospital

  STUDY CHAIR

• Bernadette Brennan, MD

  Royal Manchester Children's Hospital

  STUDY CHAIR

• Max Van Noesel, MD, PhD

  Erasmus MC-Sophia Children's Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2010
• Last Updated: August 12, 2013

Record last verified: 2009-07

Locations

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