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

This study has been completed.
Information provided by:
University Hospital Tuebingen Identifier:
First received: September 13, 2005
Last updated: April 19, 2007
Last verified: April 2007
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 Intervention Phase
Sarcoma, Soft Tissue Drug: Adriamycin Drug: Ifosfamide Drug: Etoposide Drug: Carboplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Study Start Date: February 1999
Study Completion Date: December 2006

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

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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Please refer to this study by its identifier: NCT00204646

Medical Center II, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Joerg T. Hartmann, MD South West German Cancer Center, Medical Center II, University of Tuebingen
  More Information Identifier: NCT00204646     History of Changes
Other Study ID Numbers: jth_005
Study First Received: September 13, 2005
Last Updated: April 19, 2007

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Isophosphamide mustard
Liposomal 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 processed this record on September 21, 2017