A Phase 2 interventional study of Ifosfamide in Soft Tissue Sarcoma, sponsored by Grupo Espanol de Investigacion en Sarcomas. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-20.
Sponsored by Grupo Espanol de Investigacion en Sarcomas · Phase 2, Interventional, and Treatment
To study the activity and toxicity of a neoadjuvant regimen including high-dose ifosfamide in combination with radiotherapy, and subsequent surgery, in high-risk soft tissue sarcomas.
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Grupo Espanol de Investigacion en Sarcomas is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
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Primary tumour:
Exclusion Criteria:
Drug: Ifosfamide
3 cycles of Ifosfamide (12g/m2) associated to Mesna (6g/m2), in i.v infusion 6 days, every 3 weeks
The efficacy of the neoadyuvant high-dose of ifosfamide and radiotherapy, determined with clinical and pathological responses
Time frame: 10 weeks since the inclusion of the patient
Global survival, free relapse survival and toxicity
Time frame: Until relapse or patient´s death
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Grupo Espanol de Investigacion en Sarcomas