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Sponsored by: |
Fudan University |
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Information provided by: | Fudan University |
ClinicalTrials.gov Identifier: | NCT00568464 |
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 | Intervention | Phase |
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Ewing's Sarcoma |
Drug: VCR,CTX,ADM;IFO,VP-16 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors |
Estimated Enrollment: | 30 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | September 2009 |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: VCR,CTX,ADM;IFO,VP-16
VCD:VCR 2mg d1,CTX 1200mg/m2 d1,Mesna 240mg/m2 tid d1,ADM 75mg/m2 d1,G-CSF 300ug/d d5-11;IE:IFO 1800mg/m2 d1-5,Mesna 360mg/m2 tid d1-5,VP-16 100mg/m2 d1-5,G-CSF 300ug/d d6-12;q3w.Surgery or radiation will be done to the patients with local diseases after four cycles of VCD/IE.
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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.
Ages Eligible for Study: | 10 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ye Guo, M.D. | 8613501678472 | pattrick_guo@msn.com |
China | |
Fudan University Cancer Hospital | Recruiting |
Shanghai, China, 200032 | |
Contact: Haiyi Guo, MD 8613818068164 | |
Principal Investigator: Ye Guo, M.D. |
Principal Investigator: | Ye Guo, M.D. | Fudan University Cancer Hospital |
Responsible Party: | Fudan University cancer hospital ( Base for drug clinical trials, Fudan University cancer hospital ) |
Study ID Numbers: | VCD/IE-ESFT |
Study First Received: | December 5, 2007 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00568464 |
Health Authority: | China: Ethics Committee |
ESFT(Ewing's sarcoma family of tumors) Response rate TTP OS Toxicity |
Neoplasms, Connective and Soft Tissue Ewing's sarcoma Sarcoma, Ewing's Ewing's family of tumors Malignant mesenchymal tumor Sarcoma |
Osteosarcoma Mesna Etoposide phosphate Etoposide Osteogenic sarcoma Soft tissue sarcomas |
Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue |