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

• Sponsor: Grupo Espanol de Investigacion en Sarcomas (Other)
• Overall Status: Completed
• CT.gov ID: NCT01102608
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 0.7

Study Details

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.

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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• 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: Mar 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Global survival, free relapse survival and toxicity [Until relapse or patient´s death]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

3. Size ³ 5 cm of diameter

4. Histological grade 2-3

5. Deep location

6. No distant metastases

7. Patients must have not been previously treated with Chemotherapy or Radiotherapy on the tumour area.

8. However patients are eligible with local relapse after previous surgery.

9. Patients must be £18 and ³ 65 years old.

10. Patients must have ECOG performance status 0 to 1

11. Patients must have measurable disease by Recist Criteria.

12. 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

13. 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Mariló de Carrillo, Dr. Xavier García del Muro, Grupo Espanol de Investigacion en Sarcomas
• ClinicalTrials.gov Identifier: NCT01102608
• Other Study ID Numbers: GEIS15; Nº EudraCT:2007-005755-42
• First Posted: Apr 13, 2010
• Last Update Posted: Mar 20, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Mariló de Carrillo, Dr. Xavier García del Muro, Grupo Espanol de Investigacion en Sarcomas: sarcoma; ifosfamide
• Additional relevant MeSH terms: Sarcoma; Ifosfamide

Study Results

No Results Posted as of Mar 20, 2012