Bladder cancer battle: which chemo regimen wins before or after surgery?
NCT ID NCT01812369
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different chemotherapy drug combinations in 500 people with advanced bladder cancer that had not spread to other organs. The goal was to see which treatment worked better at stopping the cancer from coming back after surgery. Participants received either gemcitabine plus cisplatin or a stronger version of MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) before or after bladder removal surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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500 people
The number who actually took part.
- Started
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Feb 2013
- Finished
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Sep 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 to 80 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Primary tumour of the bladder * Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or glandular variants are accepted if combined with TCC) * Disease defined by a T2, T3 or T4a N0 (lymph node £ 10 mm on CT scan) M0 stadification for patients receiving neoadjuvant chemotherapy OR pT3 or pT4 OR pN+ whatever pT and M0 for patients receiving adjuvant chemotherapy * 18 ≤ age ≤ 80 years * General condition 0 or 1 as per the WHO scale * Absence of previous chemotherapy for muscle-invasive disease * Haematological function: Haemoglobin \> 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3 * Liver function: Grade\* 0 ASAT and ALAT, grade\* 0 alkaline phosphatases, normal bilirubin * Renal function: calculated (or measured) creatinine clearance ³ 40 ml/min - --- Patients covered by a social security scheme * Patient having read the information sheet and signed the informed consent form. Exclusion Criteria: * Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma * Ventricular ejection fraction \< 50% * History of cancer in the 5 years prior to entry in the trial other than basal cell skin cancer or in situ epithelioma of the cervix * Male or female patients not agreeing to use an effective method of contraception throughout the duration of treatment and for 6 months after treatment discontinuation * Pregnant women, or female subjects liable to become pregnant or currently breast-feeding, * Patient already included in another therapeutic trial on an investigational medicinal product, * Persons deprived of their freedom or under judicial protection (including guardianship) * Unable to receive medical follow-up during the trial owing to geographical, social or psychological reasons.
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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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UHRouen
Rouen, 76031, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a radioactive drug seek out and attack solid tumors?