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

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ClinicalTrials.gov Identifier: NCT01102608
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):
Mariló de Carrillo, Grupo Espanol de Investigacion en Sarcomas

Brief 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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Ifosfamide Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadyuvant High-dose Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma and Identification of Response Predictors
Study Start Date : March 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Ifosfamide
3 cycles of Ifosfamide (12g/m2) associated to Mesna (6g/m2), in i.v infusion 6 days, every 3 weeks



Primary Outcome Measures :
  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 Outcome Measures :
  1. Global survival, free relapse survival and toxicity [ Time Frame: Until relapse or patient´s death ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102608


Locations
Spain
Grupo Espanol de Investigación en Sarcomas
Barcelona, España, Spain, 08006
Sponsors and Collaborators
Grupo Espanol de Investigacion en Sarcomas
Investigators
Study Chair: Xavier García del Muro, Doctor Grupo Español de Investigacion en Sarcomas

Additional Information:
Responsible Party: Mariló de Carrillo, Dr. Xavier García del Muro, Grupo Espanol de Investigacion en Sarcomas
ClinicalTrials.gov Identifier: NCT01102608     History of Changes
Other Study ID Numbers: GEIS15
Nº EudraCT:2007-005755-42
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Mariló de Carrillo, Grupo Espanol de Investigacion en Sarcomas:
sarcoma
ifosfamide

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents