Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma (NeoWTS)
|ClinicalTrials.gov Identifier: NCT01382030|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: EIA chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma|
|Study Start Date :||June 2005|
|Primary Completion Date :||September 2010|
|Study Completion Date :||January 2011|
Experimental: Treatment Arm
All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized.
Drug: EIA chemotherapy
ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1
- Disease-free survival [ Time Frame: 2 years after study completion ]Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.
- Overall Survival [ Time Frame: 2 years after study completion ]Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up.
- Grade of histological necrosis [ Time Frame: After definite surgery, approx. 12-15 weeks after study inclusion ]Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.
- Hematological toxicity [ Time Frame: Once weekly for an average of 8 months ]Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE.
- Renal Toxicity [ Time Frame: Once weekly for an average of 8 months ]Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE.
- Liver Toxicity [ Time Frame: Once weekly for an average of 8 months ]Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE.
- Correlation of Tumor Necrosis and Decline in PET SUV [ Time Frame: After tumor resection, approx. 12-15 weeks after study inclusion ]Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery.
- Cardiac Toxicity [ Time Frame: Every 6 weeks for an average of 8 months ]Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE.
- Radiologic Tumor Response [ Time Frame: Every 6 weeks for an average of 8 months, then every 3 months for 2 years ]Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382030
|Heidelberg University Clinics|
|Heidelberg, Baden-Wuerttemberg, Germany, 69120|
|Principal Investigator:||Gerlinde Egerer, MD||Department of Hematology, Heidelberg University Clinics|