Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma

NCT01382030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-06-27

No results posted yet for this study

Summary

Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Conditions

  • Soft Tissue Sarcoma

Interventions

DRUG

EIA chemotherapy

ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1

Sponsors & Collaborators

  • German Cancer Research Center

    collaborator OTHER
  • Heidelberg University

    lead OTHER

Principal Investigators

  • Gerlinde Egerer, MD · Department of Hematology, Heidelberg University Clinics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-09-30
Completion
2011-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382030 on ClinicalTrials.gov