Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)

Ewing's Sarcoma Clinical Trial

Official title:

Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00568464
• Other study ID #: VCD/IE-ESFT
• 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

• Ewing's Sarcoma
• Sarcoma
• Sarcoma, Ewing

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