Back to resultsNeoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma
Primary Purpose
Soft Tissue Sarcoma
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ifosfamide
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring sarcoma, ifosfamide
Eligibility Criteria
Inclusion Criteria:
- 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.
Primary tumour:
- Size ³ 5 cm of diameter
- Histological grade 2-3
- Deep location
- No distant metastases
- Patients must have not been previously treated with Chemotherapy or Radiotherapy on the tumour area.
- However patients are eligible with local relapse after previous surgery.
- Patients must be £18 and ³ 65 years old.
- Patients must have ECOG performance status 0 to 1
- Patients must have measurable disease by Recist Criteria.
- 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
- Signed informed consent prior to any study specific procedures
Exclusion Criteria:
- Patients with cerebral metastasis
- Pregnant or breast feeding patients.
- Active infection or other concomitant severe illness.
- Severe psychiatric illness which would not make possible the obtention of the informed consent
- Concurrent treatment with other experimental drugs within 30 days prior to study entry.
- 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.
Sites / Locations
- Grupo Espanol de Investigación en Sarcomas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
The efficacy of the neoadyuvant high-dose of ifosfamide and radiotherapy, determined with clinical and pathological responses
Secondary Outcome Measures
Global survival, free relapse survival and toxicity
Full Information
NCT ID
NCT01102608
First Posted
April 12, 2010
Last Updated
March 19, 2012
Sponsor
Grupo Espanol de Investigacion en Sarcomas
1. Study Identification
Unique Protocol Identification Number
NCT01102608
Brief Title
Neoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma
Official Title
Phase II Study of Neoadyuvant High-dose Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma and Identification of Response Predictors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo Espanol de Investigacion en Sarcomas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
sarcoma, ifosfamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Description
3 cycles of Ifosfamide (12g/m2) associated to Mesna (6g/m2), in i.v infusion 6 days, every 3 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Global survival, free relapse survival and toxicity
Time Frame
Until relapse or patient´s death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Primary tumour:
Size ³ 5 cm of diameter
Histological grade 2-3
Deep location
No distant metastases
Patients must have not been previously treated with Chemotherapy or Radiotherapy on the tumour area.
However patients are eligible with local relapse after previous surgery.
Patients must be £18 and ³ 65 years old.
Patients must have ECOG performance status 0 to 1
Patients must have measurable disease by Recist Criteria.
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
Signed informed consent prior to any study specific procedures
Exclusion Criteria:
Patients with cerebral metastasis
Pregnant or breast feeding patients.
Active infection or other concomitant severe illness.
Severe psychiatric illness which would not make possible the obtention of the informed consent
Concurrent treatment with other experimental drugs within 30 days prior to study entry.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier García del Muro, Doctor
Organizational Affiliation
Grupo Español de Investigacion en Sarcomas
Official's Role
Study Chair
Facility Information:
Facility Name
Grupo Espanol de Investigación en Sarcomas
City
Barcelona
State/Province
España
ZIP/Postal Code
08006
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.grupogeis.org
Description
Related Info
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Neoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma
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