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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryProportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0CT 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.
PrimaryIncidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0CT 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 patientsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYIncidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-upEligible and treated patientsParticipantsCOUNT_OF_PARTICIPANTS

Results by group116

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0GemcitabinePartial response1Participants
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0GemcitabineComplete response0Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 0Leukopenia6Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 1 (CTCAE v 3.0)Leukopenia6Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 2 (CTCAE v 3.0)Leukopenia8Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 3 (CTCAE v 3.0)Leukopenia3Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 4 (CTCAE v 3.0)Leukopenia0Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 5 (CTCAE v 3.0)Leukopenia0Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 0Thrombocytopenia5Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0Grade 1 (CTCAE v 3.0)Thrombocytopenia11Participants

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDGemcitabine24
Overall StudyCOMPLETEDGemcitabine23
Overall StudyNOT COMPLETEDGemcitabine1

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNeutrophilsBlood and lymphatic system disordersGemcitabine1623
otherPlateletsBlood and lymphatic system disordersGemcitabine2023
otherLeukocytesBlood and lymphatic system disordersGemcitabine1823
otherLymphopeniaBlood and lymphatic system disordersGemcitabine123
otherHemoglobinBlood and lymphatic system disordersGemcitabine2223
otherPulmonary HypertensionCardiac disordersGemcitabine123
otherHypertensionCardiac disordersGemcitabine123
otherHypotensionCardiac disordersGemcitabine123
otherInrVascular disordersGemcitabine123
otherPttVascular disordersGemcitabine123

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityGemcitabine
Total, other adverse eventsGemcitabine2323
Total, serious adverse eventsGemcitabine823

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U10CA027469Gynecologic Oncology GroupDISAIA, PHILIP J.GYNECOLOGIC ONCOLOGY GROUPNATIONAL CANCER INSTITUTE1985 to 2013

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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