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:

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Ifosfamide Etoposide Carboplatin

Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma X-linked Ichthyosis

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 (Adult)
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


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, 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

ClinicalTrials.gov processed this record on September 29, 2016

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