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

Sarcoma, Soft Tissue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204646
• Other study ID #: jth_005
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 19, 2007
• Start date: February 1999
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Soft Tissue

Intervention

Drug:
• Adriamycin

• Ifosfamide

• Etoposide

• Carboplatin

Locations

Country	Name	City	State
Germany	Medical Center II, University of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany,