Health Condition 1: null- patients with unresectable soft tissue sarcoma
Conditions
Interventions
Intervention1: Ifosfamide 1.8gm/m2 d1-d5
Inj. Epirubicin 60mg/m2 d1-d2: three weekly cycle
Three cycles
intravenous route total duration nine weeks
Control Intervention1: Not applicable: Not applicab
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Either gender with age >=18 years Non-metastatic histologically proven soft tissue sarcoma Chemotherapy naïve upfront or locally recurrent tumor which is either unresectable or resectable with an undesirable outcome Tumor size >= 5 cm + grade II/III tumors ECOG PS Normal organ function (cardiac, liver, renal)
Exclusion criteria
Exclusion criteria: Patients who refuse to give a written informed consent Histology like Ewingâ??s sarcoma, DFSP, epitheloid sarcoma, osteosarcoma, chondrosarcomas, alveolar soft part sarcoma, well differentiated liposarcoma, Rhabdomyosarcoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the overall response rate with use of neoadjuvant chemotherapy in patients with unresectable soft tissue sarcoma or soft tissuse sarcoma resectable with adverse functional outcomesTimepoint: After three cycles of chemotherapy or at clinical/radiological progression | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine association between radiological response and progression free survival To study p53 expression as prognostic biomarker To assess the limb salvage rate in with use of Neoadjuvant chemotherapyTimepoint: 31st May 2018 | — |
Countries
India
Contacts
Public ContactAkash Tiwari
AIIMS
Outcome results
None listed