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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), July 2009

First Received: June 7, 2006 Last Updated: August 7, 2009 History of Changes

Sponsor:	European Paediatric Soft Tissue Sarcoma Study Group
Collaborators:	Italian Association for Pediatric Hematology Oncology Cooperative Weichteilsarkom Studie Children's Cancer and Leukaemia Group Dutch Childhood Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00334854

Purpose

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
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma	Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma Surgery

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Ifosfamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival [ Designated as safety issue: No ]
Local relapse-free survival [ Designated as safety issue: No ]
Metastases-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease) [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	March 2006
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334854

Show 28 Study Locations

Sponsors and Collaborators

European Paediatric Soft Tissue Sarcoma Study Group

Italian Association for Pediatric Hematology Oncology

Cooperative Weichteilsarkom Studie

Children's Cancer and Leukaemia Group

Dutch Childhood Oncology Group

Investigators

Study Chair:	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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00334854 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Histiocytoma, Malignant Fibrous
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Histiocytoma, Benign Fibrous
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Neoplasms, Connective and Soft Tissue
Neoplasms

Ifosfamide
Histiocytoma
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Alkylating Agents
Isophosphamide mustard

ClinicalTrials.gov processed this record on November 27, 2009