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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mariló de Carrillo, Grupo Espanol de Investigacion en Sarcomas
ClinicalTrials.gov Identifier:
NCT01102608
First received: April 12, 2010
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Soft Tissue Sarcoma
Drug: Ifosfamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Grupo Espanol de Investigacion en Sarcomas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global survival, free relapse survival and toxicity [ Time Frame: Until relapse or patient´s death ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ifosfamide
3 cycles of Ifosfamide (12g/m2) associated to Mesna (6g/m2), in i.v infusion 6 days, every 3 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: April 12, 2010
Last Updated: March 19, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Keywords provided by 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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014