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NCT Number: NCT01382030

Neoadjuvant and Adjuvant Chemotherapy 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.

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Key information

Conditions

Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heidelberg University Clinics

Heidelberg, Baden-Wurttemberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EIA chemotherapy

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • German Cancer Research Center

Registry information

Official study title

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

Acronym: NeoWTS

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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