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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:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204646
First received: September 13, 2005
Last updated: April 19, 2007
Last verified: April 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:
Study Start Date: February 1999
Study Completion Date: December 2006
  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00204646     History of Changes
Other Study ID Numbers: jth_005
Study First Received: September 13, 2005
Last Updated: April 19, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Doxorubicin
Ifosfamide
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
 Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on March 03, 2015