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.