Role of pre-surgery chemotherapy in unresectable soft tissue sarcoma
Phase 2
- Conditions
- Health Condition 1: null- patients with unresectable soft tissue sarcoma
- Registration Number
- CTRI/2017/07/008997
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 25
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 <= 2
Normal organ function (cardiac, liver, renal)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To determine association between radiological response and progression free survival <br/ ><br>To study p53 expression as prognostic biomarker <br/ ><br>To assess the limb salvage rate in with use of Neoadjuvant chemotherapyTimepoint: 31st May 2018