Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT04047693|
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Muscle Invasive Bladder Cancer Urothelial Carcinoma Neoadjuvant Chemotherapy||Drug: dose dense MVAC with pegylated GCSF||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, Single institution, Open-label, Phase 2|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Neoadjuvant Chemotherapy With Dose Dense MVAC Followed by Radical Surgery in Patients With MIBC and Locally Advanced Urothelial Carcinoma of Bladder: Phase II, Single-arm Study|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
4 cycles of neoadjuvant chemotherapy using dose dense MVAC with G-CSF
Drug: dose dense MVAC with pegylated GCSF
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
- Rate of pathologic complete response (pCR rate) [ Time Frame: From date of enrollment until curative intended surgical treatment, assess up to 2 years ]No residual tumor (ypT0N0) in surgical specimen
- Rate of pathologic response [ Time Frame: From date of enrollment until curative intended surgical treatment, assess up to 2 years ]No residual tumor (ypT0N0) and partial response (ypTisN0) in surgical specimen
- Overall survival (OS) [ Time Frame: From date of enrollment until death, assess up to 3 years ]Time from enrollment until death from any cause
- Event free survival (EFS) [ Time Frame: From date of enrollment until death, assess up to 3 years ]Time from enrollment until the earliest occurrence of disease progression in inoperablity, locoregional recurrence, distant metastasis, or death from any cause
- Adverse events related with ddMVAC [ Time Frame: From date of enrollment until 8 weeks after last chemotherapy of ddMVAC ]Adverse events related with ddMVAC using CTCAE 4.0
- Surgical treatment related complication [ Time Frame: From surgical treatment until 60 the days after surgical treatment ]Surgical treatment related complication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047693
|Contact: Kwonoh Park, MD, PhDemail@example.com|
|Contact: Bora Kimfirstname.lastname@example.org|
|Korea, Republic of|
|Pusan National University Yangsan Hospital||Recruiting|
|Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612|
|Contact: Kwonoh Park, MD, PhD 82+-10-3378-3529 email@example.com|
|Principal Investigator:||Kwonoh Park, MD, PhD||Pusan National University Yangsan Hospital|