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Phase II Study of Neoadyuvant High-dose Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma and Identification of Response Predictors

Phase 2
18 Years
65 Years
Not Enrolling
Soft Tissue Sarcoma

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Trial Information

Phase II Study of Neoadyuvant High-dose Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma and Identification of Response Predictors

This is a phase II multicenter study designed in two phases. A total of 32 patients will be
included in 10 hospitals belonging to the Spanish Group for Research in Sarcomas (GEIS).
Selection criteria are: patients with localized soft tissue sarcoma from the extremities or
trunk with high-risk features (>5 cm and grade 2-3), or recurrences after prior inadequate
surgery. The treatment schedule will be: initial biopsy, 3 cycles of high-dose Ifosfamide,
12 gr/m2 in 5 days, concurrent with Radiotherapy 50 Gy, and subsequent wide surgery. To
assess the predictive factors of response to the combination therapy, DNA and RNA extraction
will be performed on the pretreatment biopsies. DNA will be used to hybridize Affymetrix
GeneChip® Human Mapping 500K Array, which allows for the study of 500000 SNPs throughout the
genome. The expression of 39000 RNA transcripts will be evaluated employing the Affymetrix
Genechip Human Genome HG-U133 Plus 2.0, and validated by real-time RT-PCR.

Inclusion Criteria:

1. Patients with Advanced Soft Tissue Sarcoma histological proven, potentially resected,
located in extremities and trunk for one of the following histological subtypes:
leiomyosarcoma, undifferentiated pleomorphic sarcoma, Synovial Sarcoma, Liposarcoma
and malignant tumour of peripheral nerve sheath.

2. Primary tumour:

1. Size ³ 5 cm of diameter

2. Histological grade 2-3

3. Deep location

3. No distant metastases

4. Patients must have not been previously treated with Chemotherapy or Radiotherapy on
the tumour area.

5. However patients are eligible with local relapse after previous surgery.

6. Patients must be £18 and ³ 65 years old.

7. Patients must have ECOG performance status 0 to 1

8. Patients must have measurable disease by Recist Criteria.

9. Absolute neutrophil count ³1,500/mm3, platelet count ³ 100,060 ml/min, creatinine,
total bilirubin, ALT and AST £ 1.5 times the upper limit of normal

10. Signed informed consent prior to any study specific procedures

Exclusion Criteria:

1. Patients with cerebral metastasis

2. Pregnant or breast feeding patients.

3. Active infection or other concomitant severe illness.

4. Severe psychiatric illness which would not make possible the obtention of the
informed consent

5. Concurrent treatment with other experimental drugs within 30 days prior to study

6. History of previous treated or diagnosed cancer in the past 5 years, excepting
basocellular cell skin cancer, cervix cancer in situ or superficial bladder

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The efficacy of the neoadyuvant high-dose of ifosfamide and radiotherapy, determined with clinical and pathological responses

Outcome Time Frame:

10 weeks since the inclusion of the patient

Safety Issue:


Principal Investigator

Xavier García del Muro, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Grupo Español de Investigacion en Sarcomas


Spain: Comité Ético de Investigación Clínica

Study ID:




Start Date:

March 2008

Completion Date:

December 2011

Related Keywords:

  • Soft Tissue Sarcoma
  • sarcoma
  • ifosfamide
  • Sarcoma