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

This study has been completed.
Sponsor:
Collaborator:
German Cancer Research Center
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01382030
First received: June 17, 2011
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Soft Tissue Sarcoma
Drug: EIA chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 2 years after study completion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years after study completion ] [ Designated as safety issue: No ]
    Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up.

  • Grade of histological necrosis [ Time Frame: After definite surgery, approx. 12-15 weeks after study inclusion ] [ Designated as safety issue: No ]
    Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.

  • Hematological toxicity [ Time Frame: Once weekly for an average of 8 months ] [ Designated as safety issue: Yes ]
    Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE.

  • Renal Toxicity [ Time Frame: Once weekly for an average of 8 months ] [ Designated as safety issue: Yes ]
    Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE.

  • Liver Toxicity [ Time Frame: Once weekly for an average of 8 months ] [ Designated as safety issue: Yes ]
    Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE.

  • Correlation of Tumor Necrosis and Decline in PET SUV [ Time Frame: After tumor resection, approx. 12-15 weeks after study inclusion ] [ Designated as safety issue: No ]
    Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery.

  • Cardiac Toxicity [ Time Frame: Every 6 weeks for an average of 8 months ] [ Designated as safety issue: Yes ]
    Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE.

  • Radiologic Tumor Response [ Time Frame: Every 6 weeks for an average of 8 months, then every 3 months for 2 years ] [ Designated as safety issue: No ]
    Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria.


Enrollment: 50
Study Start Date: June 2005
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382030

Locations
Germany
Heidelberg University Clinics
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
German Cancer Research Center
Investigators
Principal Investigator: Gerlinde Egerer, MD Department of Hematology, Heidelberg University Clinics
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. med. Gerlinde Egerer, Department of Hematology, Heidelberg University Clinics
ClinicalTrials.gov Identifier: NCT01382030     History of Changes
Other Study ID Numbers: 2004-002501-72, 2004-002501-72
Study First Received: June 17, 2011
Last Updated: June 23, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Soft tissue sarcoma
High-risk
Neoadjuvant
Adjuvant
Chemotherapy
Radiotherapy

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 14, 2014