Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)
Phase 2
Terminated
- Conditions
- Ewing's Sarcoma
- Interventions
- Drug: VCR, CTX, ADM; IFO, VP-16
- Registration Number
- NCT00568464
- Lead Sponsor
- Fudan University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Age range 10-65 years old
- Histological confirmed ESFT
- No previous therapy
- ECOG performance status less than 2
- Life expectancy of more than 12 weeks
- Normal laboratory values: hemoglobin>8.0g/dl, neutrophil>2×109/L, platelet > 80×109/L, Hb > 80×1012/L, serum creatine < 1×upper limitation of normal(ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN
Exclusion Criteria
- Pregnant or lactating women
- Received treatment for the disease previously
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis and bone marrow involvement
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- History of allergy to the drugs in this trial
- Abnormal LVEF level
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A VCR, CTX, ADM; IFO, VP-16 -
- Primary Outcome Measures
Name Time Method Response Rate every two cycles
- Secondary Outcome Measures
Name Time Method Toxicity every cycle
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China