Trial · NCT00238121
Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
NCT00238121, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer. Trials, record NCT00238121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00238121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer
- NCT number
- NCT00238121
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Uterine Sarcoma, Stage III Uterine Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma
- Interventions
- sorafenib tosylate
- First posted
- 2005-10-13
- Last updated
- 2015-11-20
- Results first posted
- 2014-06-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Overall Response Rate | Up to 5 years | 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. |
| Secondary | Overall Survival | Up to 5 years | 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. |
| Secondary | Progression Free Survival | Up to 5 years | 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. |
| Secondary | Duration of Response | Up to 5 years | 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 ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Overall Response Rate | Up to 5 years | participants | NUMBER | |
| SECONDARY | Overall Survival | Up to 5 years | Month | MEDIAN | |
| SECONDARY | Progression Free Survival | Up to 5 years | Month | MEDIAN | |
| SECONDARY | Duration of Response | Up to 5 years | Month | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Overall Response Rate | Carcinoma | 2 | participants | ||
| Objective Overall Response Rate | Carcinosarcoma | 0 | participants | ||
| Overall Survival | Carcinoma | 11.4 | 95% Confidence Interval 6.9 to 17.7 | Month | |
| Overall Survival | Carcinosarcoma | 5 | 95% Confidence Interval 1.4 to 14 | Month | |
| Progression Free Survival | Carcinoma | 3.2 | 95% Confidence Interval 1.9 to 4 | Month | |
| Progression Free Survival | Carcinosarcoma | 1.8 | 95% Confidence Interval 1.4 to 3.5 | Month | |
| Duration of Response | Carcinoma | 25 | Full Range 10 to 40 | Month |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carcinoma | 40 | |
| Overall Study | STARTED | Carcinosarcoma | 16 | |
| Overall Study | COMPLETED | Carcinoma | 37 | |
| Overall Study | COMPLETED | Carcinosarcoma | 14 | |
| Overall Study | NOT COMPLETED | Carcinoma | 3 | |
| Overall Study | NOT COMPLETED | Carcinosarcoma | 2 |
Source ClinicalTrials.gov
Adverse events85
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Sorafenib | 13 | 56 | |
| other | Alkaline phosphatase | Investigations | Sorafenib | 16 | 56 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Sorafenib | 13 | 56 | |
| other | Anorexia | Metabolism and nutrition disorders | Sorafenib | 25 | 56 | |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Sorafenib | 18 | 56 | |
| other | Bicarbonate, serum-low | Investigations | Sorafenib | 5 | 56 | |
| other | Bilirubin (hyperbilirubinemia) | Investigations | Sorafenib | 4 | 56 | |
| other | Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | Sorafenib | 6 | 56 | |
| other | Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | Sorafenib | 14 | 56 | |
| other | Constipation | Gastrointestinal disorders | Sorafenib | 16 | 56 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib | ||
| Total, other adverse events | Sorafenib | 56 | 56 |
| Total, serious adverse events | Sorafenib | 11 | 56 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Carcinoma vs Carcinosarcoma: Objective Overall Response Rate |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00238121
GET https://conductscience.org/api/trials/v1/NCT00238121/events?page=2