Trial · NCT00820898
Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer
NCT00820898, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2017-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer. Trials, record NCT00820898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00820898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer
- NCT number
- NCT00820898
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Recurrent Uterine Corpus Carcinoma
- Interventions
- Gemcitabine Hydrochloride
- First posted
- 2009-01-12
- Last updated
- 2017-12-29
- Results first posted
- 2017-12-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion 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 | Proportion 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 | COUNT_OF_PARTICIPANTS |
| 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 | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Gemcitabine | Partial response | 1 | Participants | |
| Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Gemcitabine | Complete response | 0 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 0 | Leukopenia | 6 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 1 (CTCAE v 3.0) | Leukopenia | 6 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 2 (CTCAE v 3.0) | Leukopenia | 8 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 3 (CTCAE v 3.0) | Leukopenia | 3 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 4 (CTCAE v 3.0) | Leukopenia | 0 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 5 (CTCAE v 3.0) | Leukopenia | 0 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 0 | Thrombocytopenia | 5 | Participants | |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Grade 1 (CTCAE v 3.0) | Thrombocytopenia | 11 | Participants |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine | 24 | |
| Overall Study | COMPLETED | Gemcitabine | 23 | |
| Overall Study | NOT COMPLETED | Gemcitabine | 1 |
Source ClinicalTrials.gov
Adverse events90
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 | Neutrophils | Blood and lymphatic system disorders | Gemcitabine | 16 | 23 | |
| other | Platelets | Blood and lymphatic system disorders | Gemcitabine | 20 | 23 | |
| other | Leukocytes | Blood and lymphatic system disorders | Gemcitabine | 18 | 23 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Gemcitabine | 1 | 23 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Gemcitabine | 22 | 23 | |
| other | Pulmonary Hypertension | Cardiac disorders | Gemcitabine | 1 | 23 | |
| other | Hypertension | Cardiac disorders | Gemcitabine | 1 | 23 | |
| other | Hypotension | Cardiac disorders | Gemcitabine | 1 | 23 | |
| other | Inr | Vascular disorders | Gemcitabine | 1 | 23 | |
| other | Ptt | Vascular disorders | Gemcitabine | 1 | 23 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine | ||
| Total, other adverse events | Gemcitabine | 23 | 23 |
| Total, serious adverse events | Gemcitabine | 8 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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/NCT00820898
GET https://conductscience.org/api/trials/v1/NCT00820898/results?page=2