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

NCT ID: NCT00204646

Last Updated: 2007-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma, Soft Tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Adriamycin

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Principal Investigators

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Joerg T. Hartmann, MD

Role: PRINCIPAL_INVESTIGATOR

South West German Cancer Center, Medical Center II, University of Tuebingen

Locations

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Medical Center II, University of Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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jth_005

Identifier Type: -

Identifier Source: org_study_id