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

Soft Tissue Sarcoma Clinical Trial

Official title:

Phase II Study of Neoadyuvant High-dose Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma and Identification of Response Predictors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102608
• Other study ID #: GEIS15
• Secondary ID: Nº EudraCT:2007-
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2010
• Last updated: March 19, 2012
• Start date: March 2008
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Grupo Espanol de Investigacion en Sarcomas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

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

Locations

Country	Name	City	State
Spain	Grupo Espanol de Investigación en Sarcomas	Barcelona	España

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de Investigacion en Sarcomas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of the neoadyuvant high-dose of ifosfamide and radiotherapy, determined with clinical and pathological responses		10 weeks since the inclusion of the patient	No
Secondary	Global survival, free relapse survival and toxicity		Until relapse or patient´s death	Yes

External Links

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