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

Primary Purpose

Ewing's Sarcoma

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

VCR, CTX, ADM; IFO, VP-16

About this trial

This is an interventional treatment trial for Ewing's Sarcoma focused on measuring ESFT (Ewing's sarcoma family of tumors), Response rate, TTP, OS, Toxicity

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Toxicity

Full Information

NCT ID

NCT00568464

First Posted

December 5, 2007

Last Updated

July 6, 2009

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00568464

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Terminated

Why Stopped

The enrollment is slower than expected

Study Start Date

March 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ewing's Sarcoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VCR, CTX, ADM; IFO, VP-16

Other Intervention Name(s)

VCD/IE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Response Rate

Time Frame

every two cycles

Secondary Outcome Measure Information:

Title

Toxicity

Time Frame

every cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Guo, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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