The objective is to investigate the efficacy and safety of four cycles of ddMVAC with G-CSF support in patients with MIBC and locally advanced UC
* Currently, most treatment guidelines including NCCN recommend a neoadjuvant chemotherapy (NAC) as a standard of care in muscle invasive bladder cancer (MIBC). * Although standard NAC regimen is controversial due to rare of head to head study between each regimens, cisplatin based multidrug combination regimens such as MVAC, GP, and dose dense MVAC (ddMVAC) with G-CSF supports are regarded as a backbone treatment on the basis of the results from previous studies. * Application of NAC is still relatively slow adoption in real practice. These slow adoption result from intuitive concerns such as significant toxicity of multidrug combination chemotherapy represented by MVAC and delayed application of radical surgical treatment in non-responder * The ddMVAC with G-CSF support regimen showed an improved efficacy compared with GP regimen, and tolerable compared with standard MVAC using application of routine G-CSF support and high intensity of cisplatin. * In case of clinically lymph node evolvement (cN+) is not for strict NAC, but patient with cN+ UC have been treated induction chemotherapy of similar NAC regimens and surgical treatment. So, this study included MIBC plus cN+ UC as locally advanced UC. * In Korea, there is a low adoption of NAC, additionally rare of ddMVAC with G-CFS in locally advanced UC. It is supposed concerns related with toxicity of ddMVAC. Although the concern is likely not true considering the previous result of the Western, there has not been studied ddMVAC as NAC in Asian including Korean. * The objective of this trial is to assess the efficacy and safety of four cycles of ddMVAC with G-CSF support in patients with locally advanced UC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Methotrexate, 30 mg/m2 IV bolus, Day 1 Vinblastine, 3 mg/m2 IV bolus, Day2 Doxorubicin, 30 mg/m2 IV bolus, Day2 Cisplatin, 70 mg/m2 IV over 1hr, Day2 Pegylated G-CSF, 6mg SC, Day 3 every 2 weeks
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
RECRUITINGRate of pathologic response
No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen
Time frame: From date of enrollment until curative intended surgical treatment, assess up to 2 years
Rate of pathologic complete response (pCR rate)
No residual tumor (ypT0N0) in surgical specimen
Time frame: From date of enrollment until curative intended surgical treatment, assess up to 2 years
Overall survival (OS)
Time from enrollment until death from any cause
Time frame: From date of enrollment until death, assess up to 3 years
Event free survival (EFS)
Time from enrollment until the earliest occurrence of disease progression in inoperablity, locoregional recurrence, distant metastasis, or death from any cause
Time frame: From date of enrollment until death, assess up to 3 years
Adverse events related with ddMVAC
Adverse events related with ddMVAC using CTCAE 4.0
Time frame: From date of enrollment until 8 weeks after last chemotherapy of ddMVAC
Surgical treatment related complication
Surgical treatment related complication
Time frame: From surgical treatment until 60 the days after surgical treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.