TriangleNCT00045630 · STUDY IN CONTEXT
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
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. 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
Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.
Overall survival is defined from the date of registration to date of death from any cause
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
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
- NCT00045630
- trial label
- S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
- 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.
- 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
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT00045630
- outcome key
- om-0000
- source section id
- NCT00045630-om-0000
- source outcome index
- 0
- endpoint
- Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
- endpoint definition
- Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.
- time origin
- up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who started treatment were included in the analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT00045630
- outcome key
- om-0001
- source section id
- NCT00045630-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival is defined from the date of registration to date of death from any cause
- time origin
- 0-2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who started treatment were included in the analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT00045630
- outcome key
- om-0002
- source section id
- NCT00045630-om-0002
- source outcome index
- 2
- endpoint
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
- endpoint definition
- Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
- time origin
- Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
- 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
- NCT00045630
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
- regimen
- Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
- analyzed count
- 74
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045630-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT00045630
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
- regimen
- Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
- analyzed count
- 74
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045630-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT00045630
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
- regimen
- Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
- analyzed count
- 74
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045630-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT00045630
- harm key
- EG000
- source section id
- NCT00045630-ae
- event group key
- EG000
- event group label
- Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
- serious affected
- 2
- serious at risk
- 74
- other affected
- 73
- other at risk
- 74
- frequency threshold
- 5
- collection period
- Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery
- 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