TriangleNCT01611662 · STUDY IN CONTEXT
Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
Reported safety
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-urethral-cancer
- nct id
- NCT01611662
- trial label
- Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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-urethral-cancer
- 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-urethral-cancer
- 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-urethral-cancer
- 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