Bladder cancer trial aims to save organs without sacrificing survival
NCT ID NCT02710734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to treat muscle-invasive bladder cancer by tailoring therapy based on each patient's tumor genetics. After initial chemotherapy, patients with a good response could avoid bladder removal and instead opt for active monitoring or less invasive treatments. The goal was to see if this personalized approach could keep cancer from spreading while preserving quality of life.
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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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78 people
The number who actually took part.
- Started
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Feb 2016
- Finished
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Dec 2025
- 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.
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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: * Male or female patients ≥18 years. * Primary urothelial or predominantly urothelial carcinoma of the bladder. * Histologic evidence of muscularis propria invasion. * AJCC27 clinical stage T2-T4a . * No radiographic evidence of lymph node positivity (N0) or metastatic disease (M0). Clinical lymphadenopathy on staging CT greater than 1.5 cm in short axis must be biopsy proven negative. * ECOG performance status 0, 1, or 2. * Left ventricular ejection fraction ≥ 50% by MUGA or ECHO within 6 months of study entry. * Normal organ and bone marrow function as defined: Leukocytes ≥ 3,000/mcL Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN Creatinine Creatinine Clearance ≥ 50 mL/min (calculated using the Cockroft-Gault formula or measured with 24 hour urine collection) Exclusion Criteria: * Any component of small cell histology. * Prior pelvic radiation therapy or patients who have undergone prior radiation to greater than or equal to 25% of the bone marrow within the past year are excluded due to risk of life threatening myelosuppression * Prior systemic chemotherapy; patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible. * Prior or concurrent malignancy of any other site except for non-melanoma skin cancer, unless disease free interval ≥ 5 years. * Patients who have received experimental agents within 4 weeks of study entry. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Adriamycin or Cisplatin or other agents used in the study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined by current oral or intravenous antibiotic therapy), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic chemotherapy. * Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cytotoxic chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Patients with hydronephrosis that has not been addressed with an intervention such as placement of a stent. * Pregnancy \& Women of Childbearing Potential
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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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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Johns Hopkins
Baltimore, Maryland, 21287, United States
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Sidney kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
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Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can intensified chemotherapy before surgery clear bladder tumors?
- Can Pre-Surgery chemotherapy outsmart aggressive bladder cancer?
- Bladder cancer: a new combo aims to avoid radical surgery
- Can a special PET scan see bladder cancer more clearly?
- Bladder cancer surgery: what happens after the bladder is removed?
- Lab-Grown tumor clusters guide tailored bladder cancer therapy