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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00568464
Recruitment Status : Terminated (The enrollment is slower than expected)
First Posted : December 6, 2007
Last Update Posted : July 7, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ewing's Sarcoma Drug: VCR, CTX, ADM; IFO, VP-16 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : May 2009
Estimated Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: A 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

Primary Outcome Measures :
  1. Response Rate [ Time Frame: every two cycles ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: every cycle ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00568464

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Ye Guo, M.D. Fudan University

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital Identifier: NCT00568464     History of Changes
Other Study ID Numbers: VCD/IE-ESFT
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Fudan University:
ESFT (Ewing's sarcoma family of tumors)
Response rate

Additional relevant MeSH terms:
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue