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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoma, Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Center II, University of Tuebingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adriamycin

Drug

ifosfamide

Drug

etoposide

Drug

carboplatin

Drug

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas

Important dates

Study start: 1999
Study completion: 2006
First posted: Sep 20, 2005
Registry last updated: Apr 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed