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Tracking Information | |||||||||||||||||||||
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First Received Date † | June 7, 2006 | ||||||||||||||||||||
Last Updated Date | February 13, 2009 | ||||||||||||||||||||
Start Date † | March 2006 | ||||||||||||||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00334854 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
Current Secondary Outcome Measures † | |||||||||||||||||||||
Original Secondary Outcome Measures † | |||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title † | Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma | ||||||||||||||||||||
Official Title † | Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas | ||||||||||||||||||||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a nonrandomized, prospective, historically controlled, multicenter study. Patients with synovial sarcoma are stratified according to the Intergroup Rhabdomyosarcoma Study (IRS) postsurgical grouping system (I vs II vs III) and tumor size ( ≤ 5 cm vs > 5 cm). Patients with adult-type soft tissue sarcoma are stratified according to the IRS postsurgical grouping system (I vs II vs III), tumor size ( ≤ 5 cm vs > 5 cm), and tumor grade (G1 vs G2 vs G3). Patients are assigned to 1 of 9 treatment groups according to disease and stratification. Synovial sarcoma
Treatment with ifosfamide repeats every 21 days for 2 courses. Patients also receive concurrent radiotherapy (concurrently with ifosfamide) 5 days a week for 5-6 weeks. After completion of radiotherapy, patients receive 1 additional course of IFO-DOX.
NOTE: * Patients undergo surgery 5 weeks after completion of chemotherapy and/or radiotherapy. NOTE: **Patients undergo radiotherapy beginning < 21 days after surgery. Adult-type soft tissue sarcoma
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study. |
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Study Phase | Phase III | ||||||||||||||||||||
Study Type † | Interventional | ||||||||||||||||||||
Study Design † | Treatment, Non-Randomized | ||||||||||||||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||||||||||||||||||
Publications * | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status † | Recruiting | ||||||||||||||||||||
Enrollment † | 250 | ||||||||||||||||||||
Completion Date | |||||||||||||||||||||
Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||||||||||||||
Ages | up to 20 Years | ||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||
Contacts †† | |||||||||||||||||||||
Location Countries † | Austria, Belgium, Denmark, France, Germany, Ireland, Spain, Sweden, Switzerland, United Kingdom | ||||||||||||||||||||
Expanded Access Status | |||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT ID † | NCT00334854 | ||||||||||||||||||||
Responsible Party | |||||||||||||||||||||
Secondary IDs †† | CCLG-EPSSG-NRSTS-2005, EU-20620, EUDRACT-2005-001139-31, UKCCSG-CTA-21275/0215/001/0001, CCLG-EpSSG-STS-2006-03 | ||||||||||||||||||||
Study Sponsor † | European Paediatric Soft Tissue Sarcoma Study Group | ||||||||||||||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||
Verification Date | April 2008 | ||||||||||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |