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Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204646
First Posted: September 20, 2005
Last Update Posted: April 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
September 13, 2005
September 20, 2005
April 20, 2007
February 1999
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Complete list of historical versions of study NCT00204646 on ClinicalTrials.gov Archive Site
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Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)
Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas
Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.
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Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sarcoma, Soft Tissue
  • Drug: Adriamycin
  • Drug: Ifosfamide
  • Drug: Etoposide
  • Drug: Carboplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2006
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Inclusion Criteria:

  • Histologically confirmed STS with locally advanced non-resectable disease
  • Metastatic disease is allowed in case of solitary resectable metastases
  • Grading according to Coindre > II°
  • Measurable tumor lesions
  • Age > 18 through 65 years
  • Karnofsky status > 70 %
  • Written informed consent

Exclusion Criteria:

  • Prior chemotherapy
  • Intercurrent disease interfering with the adequate administration of study medication including severe psychological disease
  • Insufficient liver-, renal or bone marrow function
  • Evidence of pregnancy
  • Treatment within another clinical trial
  • Uncontrolled viral Infections (HIV,HBV, HCV)
  • other malignancies
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00204646
jth_005
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University Hospital Tuebingen
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Principal Investigator: Joerg T. Hartmann, MD South West German Cancer Center, Medical Center II, University of Tuebingen
University Hospital Tuebingen
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP