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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204646

Enrollment

Unknown

Registered

2005-09-20

Start date

1999-02-28

Completion date

2006-12-31

Last updated

2007-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma, Soft Tissue

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.

Interventions

DRUGAdriamycin

DRUGIfosfamide

DRUGEtoposide

DRUGCarboplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026