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CompletedNCT00204646Updated Apr 20, 2007

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

A Phase 2 interventional study of Adriamycin and Ifosfamide in Sarcoma, Soft Tissue, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-04-20.

Sponsored by University Hospital Tuebingen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sarcoma, Soft Tissue

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03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

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Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DrugAdriamycin
  • DrugIfosfamide
  • DrugEtoposide
  • DrugCarboplatin
06

Study locations

1 site
  • Medical Center II, University of Tuebingen
    Tuebingen, 72076, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00204646
Lead sponsor
University Hospital Tuebingen
First posted
Sep 20, 2005
Start date
Feb 1999
Completion
Dec 2006
Last update
Apr 20, 2007

Study contacts

Joerg T. Hartmann, MD
principal investigator · South West German Cancer Center, Medical Center II, University of Tuebingen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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