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

Primary Purpose

Sarcoma, Soft Tissue

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Adriamycin
Ifosfamide
Etoposide
Carboplatin
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Soft Tissue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center II, University of Tuebingen

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
April 19, 2007
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00204646
Brief Title
Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Soft Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Carboplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg T. Hartmann, MD
Organizational Affiliation
South West German Cancer Center, Medical Center II, University of Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center II, University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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