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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Soft Tissue Sarcoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Description:

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.

Outcome Time Frame:

2 years after study completion

Safety Issue:

No

Principal Investigator

Gerlinde Egerer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hematology, Heidelberg University Clinics

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2004-002501-72

NCT ID:

NCT01382030

Start Date:

June 2005

Completion Date:

January 2011

Related Keywords:

  • Soft Tissue Sarcoma
  • Soft tissue sarcoma
  • High-risk
  • Neoadjuvant
  • Adjuvant
  • Chemotherapy
  • Radiotherapy
  • Sarcoma

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