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Sponsors and Collaborators: |
European Paediatric Soft Tissue Sarcoma Study Group Associazione Italiana Ematologia Oncologia Pediatrica Cooperative Weichteilsarkom Studie Children's Cancer and Leukaemia Group Dutch Childhood Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334854 |
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.
Condition | Intervention | Phase |
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Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma |
Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas |
Estimated Enrollment: | 250 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
Malignant peripheral nerve sheath tumor
No evidence of metastatic disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Andrea Ferrari, MD | Fondazione Istituto Nazionale dei Tumori |
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 ID Numbers: | CDR0000482277, CCLG-EPSSG-NRSTS-2005, EU-20620, EUDRACT-2005-001139-31, UKCCSG-CTA-21275/0215/001/0001, CCLG-EpSSG-STS-2006-03 |
Study First Received: | June 7, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00334854 |
Health Authority: | Unspecified |
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 |
Fibrosarcoma Histiocytoma, Malignant Fibrous Histiocytoma, Benign Fibrous Leiomyosarcoma Malignant mesenchymal tumor Epithelioid sarcoma Alveolar soft part sarcoma Soft tissue sarcomas Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Dermatofibrosarcoma protuberans Chondrosarcoma Sarcoma, Alveolar Soft Part |
Synovial sarcoma Hemangiosarcoma Hemangiopericytoma Dermatofibrosarcoma Doxorubicin Liposarcoma Ifosfamide Histiocytoma Mechlorethamine Sarcoma Malignant fibrous histiocytoma Isophosphamide mustard |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
Neoplasms, Connective Tissue Antibiotics, Antineoplastic Neoplasms, Fibrous Tissue Alkylating Agents Pharmacologic Actions |