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

NCT01102608 | Completed Phase 2

• 2 other identifiers: GEIS15Nº EudraCT:2007-005755-42
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma

Keywords

sarcoma; ifosfamide

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Global survival, free relapse survival and toxicity

  Until relapse or patient´s death

Study Arms (1)

1

EXPERIMENTAL

Drug: Ifosfamide

Interventions

Ifosfamide DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Espanol de Investigacion en Sarcomas: lead

Study Sites (1)

Grupo Espanol de Investigación en Sarcomas

Barcelona, España, 08006, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Sarcoma

Interventions

Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xavier García del Muro, Doctor

  Grupo Español de Investigacion en Sarcomas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Xavier García del Muro

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 13, 2010
• Study Start: March 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

ES (1)