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

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), April 2008

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
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 Procedure: radiation therapy	Phase III

MedlinePlus related topics:

Cancer Soft Tissue Sarcoma

ChemIDplus related topics:

Ifosfamide Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized

Official Title:	Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas

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 29 Study Locations

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

Investigators


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

More Information

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

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
First Received:	June 7, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00334854
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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on October 14, 2008