Can intensified chemotherapy before surgery clear bladder tumors?

NCT ID NCT04047693

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

May 2019

Finished

Oct 2023

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612, South Korea

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