CClinicalTrials.gg
CompletedNCT01102608Updated Mar 20, 2012

Neoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma

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

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Soft Tissue Sarcoma

Browse trials for

Keywords

  • sarcoma
  • ifosfamide
03

In context

Sarcoma

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 →

Lead sponsor

Grupo Espanol de Investigacion en Sarcomas is the lead sponsor of 20 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 entry.
  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 carcinoma.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    1

    Drug: Ifosfamide

Interventions

  • DrugIfosfamide

    3 cycles of Ifosfamide (12g/m2) associated to Mesna (6g/m2), in i.v infusion 6 days, every 3 weeks

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Global survival, free relapse survival and toxicity

    Time frame: Until relapse or patient´s death

07

Study locations

1 site
  • Grupo Espanol de Investigación en Sarcomas
    Barcelona, España 08006, Spain
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01102608
Lead sponsor
Grupo Espanol de Investigacion en Sarcomas
Responsible party
Mariló de Carrillo (Dr. Xavier García del Muro, Grupo Espanol de Investigacion en Sarcomas) — Principal investigator
First posted
Apr 13, 2010
Start date
Mar 2008
Primary completion
Oct 2011
Completion
Dec 2011
Last update
Mar 20, 2012

Study contacts

Xavier García del Muro, Doctor
study chair · Grupo Español de Investigacion en Sarcomas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion