Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
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ClinicalTrials.gov Identifier: NCT00003052 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: September 17, 2013
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 1, 1999 | ||||||
First Posted Date ICMJE | January 27, 2003 | ||||||
Last Update Posted Date | September 17, 2013 | ||||||
Study Start Date ICMJE | July 1997 | ||||||
Primary Completion Date | Not Provided | ||||||
Current Primary Outcome Measures ICMJE |
Local progression-free survival | ||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||
Change History | Complete list of historical versions of study NCT00003052 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma | ||||||
Official Title ICMJE | Randomized Study Comparing Neoadjuvant Chemotherapy Etoposide + Ifosfamide + Adriamycin (EIA) Combined With Regional Hyperthermia (RHT) Versus Neoadjuvant Chemotherapy Alone in the Treatment of High-Risk Soft Tissue Sarcomas in Adults | ||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not known whether receiving chemotherapy plus hyperthermia is more effective than receiving chemotherapy alone in treating patients with soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and hyperthermia therapy in treating patients with soft tissue sarcoma. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to high-risk category (S1 vs S2 vs S3) and disease site (extremity vs nonextremity). Patients are randomized to one of two treatment arms.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 340 patients (170 patients per arm) will be accrued for this study within 3.5 years. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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Condition ICMJE | Sarcoma | ||||||
Intervention ICMJE |
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Study Arms | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Estimated Enrollment ICMJE |
340 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Actual Study Completion Date | June 2010 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00003052 | ||||||
Other Study ID Numbers ICMJE | CDR0000065699 EORTC-62961 |
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Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | European Organisation for Research and Treatment of Cancer - EORTC | ||||||
Collaborators ICMJE | The European Society for Hyperthermic Oncology | ||||||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | ||||||
Verification Date | November 2006 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |