The investigators explored the activity of vincristine and irinotecan combined with temozolomide (VIT) in patients with relapsed and metastatic Ewing Sarcoma.
After standard multimodal therapy, the prognosis of relapsed and metastatic Ewing Sarcoma is dismal and unchanged over the last decades. The anti-tumor activity of VIT was demonstrated by several studies in the past. However, the detailed schedule of VIT was not decided. Thus, the investigators explored the activity of 5-d shorter schedule of VIT and 5-d x2w longer schedule of VIT in patients with relapsed and metastatic Ewing Sarcoma after the failure of first-line chemotherapy with doxorubicin, vincristine, cyclophosphamide, ifosphamide and etoposide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
vincristine 1.5mg/m2 iv D1,D8
Temozolomide 100mg/m2/d iv on days 1-5.
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGObject response rate(ORR) at 12 weeks
complete response (CR) + partial response (PR) at 12 weeks
Time frame: 4 months
Progression-free survival(PFS)
Calculated from the date of treatment start until the time of disease progression or death, whichever comes first.
Time frame: 2 years
Overall survival(OS)
Calculated from the date of treatment start until last follow-up or death, whichever comes first.
Time frame: 2 years
Duration of response(DOR)
Duration of response is calculated from the day of first response assessment until either progression/death (event) or last day of follow-up (censored).
Time frame: 2 years
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