Can intensified chemotherapy before surgery clear bladder tumors?
NCT ID NCT04047693
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers test whether four cycles of dose-dense MVAC chemotherapy, given with G-CSF support, can shrink or eliminate muscle-invasive bladder cancer before radical surgery. The trial enrolls 24 adults with locally advanced urothelial carcinoma of the bladder who are fit for cisplatin-based treatment. The main goal is to measure how many participants have no residual tumor or only early-stage disease in the surgical specimen, with survival tracked as a secondary outcome.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dose-dense MVAC chemotherapy (methotrexate, vinblastine, doxorubicin, cisplatin) with pegylated G-CSF support
- What this could lead to
- If it works, this could show that giving dose-dense MVAC before surgery helps clear bladder tumors and improves survival for people with muscle-invasive disease.
- What could go wrong
- This is a small phase 2 study with 24 participants, so results may not hold in larger groups. Dose-dense chemotherapy carries risks of low blood counts, infection, and organ toxicity.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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24 people
The number who actually took part.
- Started
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May 2019
- Finished
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Oct 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed urothelial cancer of bladder. 2. Locally advanced status for planning surgical treatment (Bladder, confirm muscle invasiveness using TURBT, or cT3-4a and N1-3 using imaging studies) 3. Age 18 years or older 4. Eastern Cooperative Oncology Group performance status 0-1 5. Adequate organ and bone marrow function for cisplatin based chemotherapy A. Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥ 1,500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9 g/dL) B. Adequate renal function: creatinine \< 1.5 x upper normal limit (UNL) or creatinine clearance(Ccr) using Cockroft and Gault formula ≥ 50 ml/min C. Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \<5.0 x UNL, alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease) 6. Women should use contraceptive medication for 6 months after the end of the study or she would be post-menopause status. Men should consent with the contraception for 6 months after the end of the study or he would be infertile. 7. Patients should sign a written informed consent before study entry. Exclusion Criteria: 1. Histologic types other than urothelial cell carcinoma should be excluded. However, urothelial cell types combined with squamous or glandular features are allowed. 2. Excess of 4 weeks after initial imaging studies. But, allow the patients to enrollment of study if they is reassessed and reconfirm the localized status using subsequent imaging studies. In this case, clinical stage is decided as following imaging studies. 3. Prior systemic chemotherapy (But prior intravesical chemotherapy was allowed) 4. Peripheral sensory neuropathy grade 2 or worse according to NCI CTCAE 5. History of treatment with drugs of another clinical trial within 30 days before enrollment. 6. Concomitant severe medical, surgical, or psychiatric disease or problems which can affect the results of the clinical trial or have possibilities of unexpected medical problems caused be the drug of clinical trial A. Unstable angina, myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months B. Active infection which would compromise the patients C. Liver cirrohosis or chronic active hepatitis D. Poor pulmonary function (DLCO ≤ 50% of normal or resting O2 saturation ≤ 90%) E. Clinically significant hemoptysis or gastrointestinal bleeding within previous 6 months F. Major psychiatric disorders or other inadequate psychiatric problems according to the physicians decision 7. History of another malignancy (but treated malignancy at least two years before enrollment were allowed, and cured non-melanoma skin cancer, any cured in-situ carcinoma, clinically insignificant localized prostate cancer, or papillary thyroid carcinoma are allowed even diagnosed less than 2 years before enrollment). 8. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
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Other studies related to the condition(s) this trial covers.
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