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← recurrent Urethral Cancer

NCT00112905 · STUDY IN CONTEXT

Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

Survival estimate from the Kaplan-Meier curve of the proportion of patients alive and progression-free at 4 months. Progression-free survival is defined as the time from registration to progression or death, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

Per protocol, the primary analysis included eligible patients who started protocol treatment.

→

secondary · POSTED

Time from registration to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

Only eligible and treated patients are included in this analysis.

→

secondary · POSTED

Time from registration to death. Patients alive at last follow-up were censored.

Only eligible and treated patients are included in this analysis.

→

secondary · POSTED

This outcome measure reports the best response a patient has ever experienced. \<Target Lesions\> Complete Response (CR): The disappearance of all target lesions, confirmed by assessments \>=4 weeks (wks) later. Partial Response: \>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments \>=4 wks later. Progressive Disease (PD): \>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions. Stable Disease (SD): Neither response criteria nor progressive disease criteria are met for \>=8 wks. \<Nontarget Lesions\> CR: The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments \>=4 wks later. SD: Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for \>=8 wks. PD: The appearance of new lesions or unequivocal progression of existing lesions.

Only eligible and treated patients are included in the analysis.

→

Reported safety

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

Open the study safety table →

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-recurrent-b677a38b
nct id
NCT00112905
trial label
Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium
applicability
unclear
applicability note
Attached because the study's own record describes recurrent 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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0000
    source section id
    NCT00112905-om-0000
    source outcome index
    0
    endpoint
    Kaplan-Meier Estimate of Progression-free Survival at 4 Months
    endpoint definition
    Survival estimate from the Kaplan-Meier curve of the proportion of patients alive and progression-free at 4 months. Progression-free survival is defined as the time from registration to progression or death, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.
    time origin
    Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Per protocol, the primary analysis included eligible patients who started protocol treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0001
    source section id
    NCT00112905-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival
    endpoint definition
    Time from registration to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.
    time origin
    Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only eligible and treated patients are included in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0002
    source section id
    NCT00112905-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Time from registration to death. Patients alive at last follow-up were censored.
    time origin
    Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only eligible and treated patients are included in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0003
    source section id
    NCT00112905-om-0003
    source outcome index
    3
    endpoint
    Best Overall Response by RECIST
    endpoint definition
    This outcome measure reports the best response a patient has ever experienced. \<Target Lesions\> Complete Response (CR): The disappearance of all target lesions, confirmed by assessments \>=4 weeks (wks) later. Partial Response: \>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments \>=4 wks later. Progressive Disease (PD): \>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions. Stable Disease (SD): Neither response criteria nor progressive disease criteria are met for \>=8 wks. \<Nontarget Lesions\> CR: The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments \>=4 wks later. SD: Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for \>=8 wks. PD: The appearance of new lesions or unequivocal progression of existing lesions.
    time origin
    Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only eligible and treated patients are included in the analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0000
    arm key
    OG000
    arm label
    TCC Cohort
    regimen
    Only eligible and treated patients are included in the analysis. BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00112905-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0001
    arm key
    OG000
    arm label
    TCC Cohort
    regimen
    Only eligible and treated patients are included in the analysis. BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00112905-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0002
    arm key
    OG000
    arm label
    TCC Cohort
    regimen
    Only eligible and treated patients are included in the analysis. BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00112905-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    outcome key
    om-0003
    arm key
    OG000
    arm label
    TCC Cohort
    regimen
    Only eligible and treated patients are included in the analysis. BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies.
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00112905-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urethral-cancer-recurrent-b677a38b
    nct id
    NCT00112905
    harm key
    EG000
    source section id
    NCT00112905-ae
    event group key
    EG000
    event group label
    TCC Cohort
    serious affected
    15
    serious at risk
    27
    other affected
    24
    other at risk
    27
    frequency threshold
    5
    collection period
    Assessed every 8 weeks
    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