Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00334854|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : June 8, 2006
Last Update Posted : August 12, 2013
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 or disease||Intervention/treatment||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 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Official Title:||Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas|
|Study Start Date :||March 2006|
|Estimated Primary Completion Date :||May 2010|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334854
|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|