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


Phase 2
10 Years
65 Years
Not Enrolling
Both
Ewing's Sarcoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate

Outcome Time Frame:

every two cycles

Safety Issue:

No

Principal Investigator

Ye Guo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

VCD/IE-ESFT

NCT ID:

NCT00568464

Start Date:

March 2007

Completion Date:

September 2009

Related Keywords:

  • Ewing's Sarcoma
  • ESFT (Ewing's sarcoma family of tumors)
  • Response rate
  • TTP
  • OS
  • Toxicity
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

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