Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

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Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id: NCT01611662
trial label: Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 1
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01611662
outcome key
om-0000
source section id
NCT01611662-om-0000
source outcome index
0
endpoint
Pathological Complete Response Rate Following Chemotherapy Before Surgery
endpoint definition
Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
time origin
Up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01611662
outcome key
om-0000
arm key
OG000
arm label
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
regimen
Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. gemcitabine hydrochloride: Given IV cisplatin: Given IV therapeutic conventional surgery: Undergo radical cystectomy laboratory biomarker analysis: Correlative studies
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01611662-om-0000#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docetaxel-5f0ad806
nct id
NCT01611662
harm key
EG000
source section id
NCT01611662-ae
event group key
EG000
event group label
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
serious affected
16
serious at risk
31
other affected
31
other at risk
31
frequency threshold
0
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice