Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma (NeoWTS)

June 23, 2011 updated by: Heidelberg University

A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • Heidelberg University Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Soft tissue sarcoma histology
  • Tumor size >= 5 cm
  • Deep/extracompartimental localization
  • Grade 2/3 (FNCLCC)
  • Patients with inadequate previous therapy
  • Age 18-65 years
  • normal bone marrow function
  • normal liver function
  • normal renal function
  • Karnofsky index >=80%

Exclusion Criteria:

  • Chordoma
  • Chondrosarcoma
  • Kaposi´ sarcoma
  • Neuroblastoma
  • Mesothelioma
  • Osteosarcoma/Ewings´sarcoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Arm
All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 2 years after study completion
Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.
2 years after study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 2 years after study completion
Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up.
2 years after study completion
Grade of histological necrosis
Time Frame: After definite surgery, approx. 12-15 weeks after study inclusion
Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.
After definite surgery, approx. 12-15 weeks after study inclusion
Hematological toxicity
Time Frame: Once weekly for an average of 8 months
Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE.
Once weekly for an average of 8 months
Renal Toxicity
Time Frame: Once weekly for an average of 8 months
Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE.
Once weekly for an average of 8 months
Liver Toxicity
Time Frame: Once weekly for an average of 8 months
Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE.
Once weekly for an average of 8 months
Correlation of Tumor Necrosis and Decline in PET SUV
Time Frame: After tumor resection, approx. 12-15 weeks after study inclusion
Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery.
After tumor resection, approx. 12-15 weeks after study inclusion
Cardiac Toxicity
Time Frame: Every 6 weeks for an average of 8 months
Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE.
Every 6 weeks for an average of 8 months
Radiologic Tumor Response
Time Frame: Every 6 weeks for an average of 8 months, then every 3 months for 2 years
Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria.
Every 6 weeks for an average of 8 months, then every 3 months for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

German Cancer Research Center

Investigators

  • Principal Investigator: Gerlinde Egerer, MD, Department of Hematology, Heidelberg University Clinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-002501-72 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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