Trial · NCT00379145
Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
NCT00379145, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2017-12-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus. Trials, record NCT00379145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00379145
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
- NCT number
- NCT00379145
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Sarcoma
- Interventions
- trabectedin
- First posted
- 2006-09-21
- Last updated
- 2017-12-12
- Results first posted
- 2017-12-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years. | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. |
| Primary | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years. | Eligible and treated patients | participants | NUMBER |
| PRIMARY | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up | Eligible and treated patients | participants | NUMBER |
Source ClinicalTrials.gov
Results by group137
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Trabectidin | Partial response | 2 | participants | |
| Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Trabectidin | Complete response | 0 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 0 | Leukopenia | 2 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 1 (CTCAE v 3.0) | Leukopenia | 0 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 2 (CTCAE v 3.0) | Leukopenia | 7 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 3 (CTCAE v 3.0) | Leukopenia | 10 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 4 (CTCAE v 3.0) | Leukopenia | 1 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 0 | Thrombocytopenia | 13 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 1 (CTCAE v 3.0) | Thrombocytopenia | 4 | participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 2 (CTCAE v 3.0) | Thrombocytopenia | 0 | participants |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trabectidin | 20 | |
| Overall Study | COMPLETED | Trabectidin | 20 | |
| Overall Study | NOT COMPLETED | Trabectidin | 0 |
Source ClinicalTrials.gov
Adverse events114
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 | Rhinitis | Immune system disorders | Trabectidin | 1 | 20 | |
| other | Tinnitus | Ear and labyrinth disorders | Trabectidin | 1 | 20 | |
| other | Neutrophils | Blood and lymphatic system disorders | Trabectidin | 18 | 20 | |
| other | Platelets | Blood and lymphatic system disorders | Trabectidin | 8 | 20 | |
| other | Leukocytes | Blood and lymphatic system disorders | Trabectidin | 18 | 20 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Trabectidin | 2 | 20 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Trabectidin | 17 | 20 | |
| other | Palpitations | Cardiac disorders | Trabectidin | 1 | 20 | |
| other | Cardiac Arrhythmia - Other | Cardiac disorders | Trabectidin | 1 | 20 | |
| other | Ventricular Arrhythmia - Tachycardia | Cardiac disorders | Trabectidin | 1 | 20 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trabectidin | ||
| Total, other adverse events | Trabectidin | 20 | 20 |
| Total, serious adverse events | Trabectidin | 4 | 20 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00379145
GET https://conductscience.org/api/trials/v1/NCT00379145/results?page=2