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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014