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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00568464
Other study ID # VCD/IE-ESFT
Secondary ID
Status Terminated
Phase Phase 2
First received December 5, 2007
Last updated July 6, 2009
Start date March 2007
Est. completion date September 2009

Study information

Verified date July 2009
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 10
Est. completion date September 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 65 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Fudan University Cancer Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response Rate every two cycles No
Secondary Toxicity every cycle Yes
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