Clinical trial · Interventional
Neoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma
Phase II Study of Neoadyuvant High-dose Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma and Identification of Response Predictors
NCT01102608CI-TRIAL-00006543completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Ifosfamide
Primary outcomes (1)
- measure
- The efficacy of the neoadyuvant high-dose of ifosfamide and radiotherapy, determined with clinical and pathological responses
- timeFrame
- 10 weeks since the inclusion of the patient
Secondary outcomes (1)
- measure
- Global survival, free relapse survival and toxicity
- timeFrame
- Until relapse or patient´s death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.