Preop chemoradiotherapy for sarcoma
Phase 2
- Conditions
- Soft tissue sarcoma of the extremities.Malignant neoplasm of other connective and soft tissue
- Registration Number
- IRCT20150929024266N4
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 106
Inclusion Criteria
Pathological diagnosis of soft tissue sarcoma in extremity
Tumor size over 5 cm based on CT scan or MRI
Exclusion Criteria
Not tolerating chemotherapy due to underlying renal, hepatic or cardiac problems or insufficient bone marrow reserve
Recurrent o metastatic tumors
Pregnancy or breastfeeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment-induced toxicities. Timepoint: Weekly during intervention, 4, 12 and 24 weeks after intervention. Method of measurement: Interviewing patient and physical examination including inspection and palpation, lab data and imaging.;Pathological response. Timepoint: After surgery. Method of measurement: Inspection of surgical specimen by the pathologist and defining the extent of tumor tissue necrosis.
- Secondary Outcome Measures
Name Time Method Post-op complications. Timepoint: 4 weeks after surgery. Method of measurement: Interviewing and examining the patient.;Local recurrence. Timepoint: 6,12 and 24 month after surgery. Method of measurement: Physical exam and imaging.;Distant metastasis. Timepoint: 6,12 and 24 month after surgery. Method of measurement: Physical exam and imaging.