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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568464

Enrollment

Registered

2007-12-06

Start date

2007-03-31

Completion date

2009-09-30

Last updated

2009-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ewing's Sarcoma

Keywords

ESFT (Ewing's sarcoma family of tumors), Response rate, TTP, OS, Toxicity

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.

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.

Interventions

DRUGVCR, 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Response Rate	every two cycles

Secondary

Measure	Time frame
Toxicity	every cycle

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026