NCT00238121 · STUDY IN CONTEXT

Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

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

Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.

Source null

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secondary · POSTED

Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.

Source null

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secondary · POSTED

Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.

Source null

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secondary · POSTED

Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.

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.

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-uterine-sarcoma-recurrent-8e0b2edc
nct id: NCT00238121
trial label: Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
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

release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0000
source section id
NCT00238121-om-0000
source outcome index
0
endpoint
Objective Overall Response Rate
endpoint definition
Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.
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
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0001
source section id
NCT00238121-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.
time origin
Up to 5 years
analysis role
secondary
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
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0002
source section id
NCT00238121-om-0002
source outcome index
2
endpoint
Progression Free Survival
endpoint definition
Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.
time origin
Up to 5 years
analysis role
secondary
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
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0003
source section id
NCT00238121-om-0003
source outcome index
3
endpoint
Duration of Response
endpoint definition
Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.
time origin
Up to 5 years
analysis role
secondary
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-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0000
arm key
OG000
arm label
Carcinoma
regimen
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0000
arm key
OG001
arm label
Carcinosarcoma
regimen
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0001
arm key
OG000
arm label
Carcinoma
regimen
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0001
arm key
OG001
arm label
Carcinosarcoma
regimen
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0002
arm key
OG000
arm label
Carcinoma
regimen
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
38
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0002
arm key
OG001
arm label
Carcinosarcoma
regimen
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0003
arm key
OG000
arm label
Carcinoma
regimen
Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
outcome key
om-0003
arm key
OG001
arm label
Carcinosarcoma
regimen
Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00238121-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00238121
harm key
EG000
source section id
NCT00238121-ae
event group key
EG000
event group label
Sorafenib
serious affected
11
serious at risk
56
other affected
56
other at risk
56
frequency threshold
5
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