Trial · NCT03189446
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
NCT03189446, Phase 2, Completed, University of Oklahoma; results first posted 2021-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer. Trials, record NCT03189446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03189446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
- NCT number
- NCT03189446
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- University of Oklahoma
- Conditions
- Endometrial Cancer, Papillary Serous, Clear Cell Endometrial Cancer
- Interventions
- Vaginal Cuff Brachytherapy, Carboplatin, Paclitaxel
- First posted
- 2017-06-16
- Last updated
- 2024-03-08
- Results first posted
- 2021-01-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Completing the Protocol | 4 months | Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy |
| Secondary | Frequency of Adverse Events Related to Acute Toxicity During Treatment | 4 months | Frequency and severity of adverse events as assessed by the CTCAE v4 |
| Secondary | Sites of Failure | up to 2 years | Proportion of participants who experienced failure in regional or distant sites |
| Secondary | Recurrence-free Survival | up to 2 years | time from study entry to the first tumor recurrence |
| Secondary | Contributing Cause of Death | up to 2 years | The contributing cause of death for patients with high risk endometrial cancer |
| Secondary | Overall Survival | up to 2 years | time from study entry to death |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Completing the Protocol | 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency of Adverse Events Related to Acute Toxicity During Treatment | 4 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Sites of Failure | up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Recurrence-free Survival | up to 2 years | patients who received protocol therapy | months | MEDIAN |
| SECONDARY | Contributing Cause of Death | up to 2 years | Number of patients who died following protocol treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | up to 2 years | Patients who received protocol treatment | months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Number of Patients Completing the Protocol | Vaginal Cuff Brachytherapy + Chemotherapy | 27 | Participants | ||
| Frequency of Adverse Events Related to Acute Toxicity During Treatment | Vaginal Cuff Brachytherapy + Chemotherapy | 9 | Participants | ||
| Sites of Failure | Vaginal Cuff Brachytherapy + Chemotherapy | 0 | Participants | ||
| Recurrence-free Survival | Vaginal Cuff Brachytherapy + Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Contributing Cause of Death | Vaginal Cuff Brachytherapy + Chemotherapy | Unknown cause of death | 1 | Participants | |
| Contributing Cause of Death | Vaginal Cuff Brachytherapy + Chemotherapy | Alive | 31 | Participants | |
| Overall Survival | Vaginal Cuff Brachytherapy + Chemotherapy | NA | 95% Confidence Interval NA to NA | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaginal Cuff Brachytherapy + Chemotherapy | 32 | |
| Overall Study | COMPLETED | Vaginal Cuff Brachytherapy + Chemotherapy | 27 | |
| Overall Study | NOT COMPLETED | Vaginal Cuff Brachytherapy + Chemotherapy | 5 |
Source ClinicalTrials.gov
Adverse events5
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 | Fatigue | General disorders | Vaginal Cuff Brachytherapy + Chemotherapy | 2 | 32 | |
| other | Diarrhea | Gastrointestinal disorders | Vaginal Cuff Brachytherapy + Chemotherapy | 2 | 32 | |
| other | Taxol Reaction | Immune system disorders | Vaginal Cuff Brachytherapy + Chemotherapy | 3 | 32 | |
| other | Anemia | Blood and lymphatic system disorders | Vaginal Cuff Brachytherapy + Chemotherapy | 2 | 32 | |
| other | Peripheral Neuropathy | Nervous system disorders | Vaginal Cuff Brachytherapy + Chemotherapy | 2 | 32 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaginal Cuff Brachytherapy + Chemotherapy | 1 | 32 |
| Total, other adverse events | Vaginal Cuff Brachytherapy + Chemotherapy | 10 | 32 |
| Total, serious adverse events | Vaginal Cuff Brachytherapy + Chemotherapy | 0 | 32 |
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 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/NCT03189446
GET https://conductscience.org/api/trials/v1/NCT03189446/registered