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

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Fudan University

Status and phase

Terminated
Phase 2

Conditions

Ewing's Sarcoma

Treatments

Drug: VCR, CTX, ADM; IFO, VP-16

Study type

Interventional

Funder types

Other

Identifiers

NCT00568464
VCD/IE-ESFT

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

10 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

A
Experimental group
Treatment:
Drug: VCR, CTX, ADM; IFO, VP-16

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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