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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The efficacy of the neoadyuvant high-dose of ifosfamide and radiotherapy, determined with clinical and pathological responses
10 weeks since the inclusion of the patient
No
Xavier García del Muro, Doctor
Study Chair
Grupo Español de Investigacion en Sarcomas
Spain: Comité Ético de Investigación Clínica
GEIS15
NCT01102608
March 2008
December 2011
Name | Location |
---|