Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)
The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors|
- Response Rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||September 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Drug: VCR, CTX, ADM; IFO, VP-16
VCD: VCR 2 mg d1, CTX 1200 mg/m2 d1, Mesna 240 mg/m2 tid d1, ADM 75mg/m2 d1, G-CSF 300 ug/d d5-11; IE: IFO 1800mg/m2 d1-5,Mesna 360 mg/m2 tid d1-5,VP-16 100 mg/m2 d1-5,G-CSF 300 ug/d d6-12; q3w. Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.
Other Name: VCD/IE
80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation). The survival has been improved in these 30 years due to chemotherapy. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568464
|Fudan University Cancer Hospital|
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||Ye Guo, M.D.||Fudan University|