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

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ClinicalTrials.gov Identifier: NCT00204646
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 20, 2007
Sponsor:
Information provided by:
University Hospital Tuebingen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Adriamycin Drug: Ifosfamide Drug: Etoposide Drug: Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas
Study Start Date : February 1999
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00204646


Locations
Germany
Medical Center II, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Joerg T. Hartmann, MD South West German Cancer Center, Medical Center II, University of Tuebingen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00204646     History of Changes
Other Study ID Numbers: jth_005
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Isophosphamide mustard
Liposomal doxorubicin
Carboplatin
Etoposide
Ifosfamide
Doxorubicin
 Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antibiotics, Antineoplastic