Trial · NCT00476086
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
NCT00476086, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2016-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus. Trials, record NCT00476086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00476086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
- NCT number
- NCT00476086
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Mixed Mullerian Tumors of the Uterus
- Interventions
- Gemcitabine, Oxaliplatin, Radiation
- First posted
- 2007-05-21
- Last updated
- 2018-08-24
- Results first posted
- 2016-04-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chemotherapy Completion Rate | 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle | Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy. |
| Secondary | Radiation Therapy Completion Rate | Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy. | Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease |
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 | Chemotherapy Completion Rate | 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle | The analysis dataset is comprised of all participants who started chemotherapy. | percentage of participants | NUMBER |
| SECONDARY | Radiation Therapy Completion Rate | Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy. | The analysis dataset is comprised of all participants who started chemotherapy. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Chemotherapy Completion Rate | Oxaliplatin/ Gemcitabine Then Radiation | 100 | 90% Confidence Interval 85 to 100 | percentage of participants | |
| Radiation Therapy Completion Rate | Oxaliplatin/ Gemcitabine Then Radiation | 79 | 90% Confidence Interval 58 to 92 | percentage of participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxaliplatin/ Gemcitabine Then Radiation | 20 | |
| Overall Study | Received Chemotherapy | Oxaliplatin/ Gemcitabine Then Radiation | 19 | |
| Overall Study | Received Radiation | Oxaliplatin/ Gemcitabine Then Radiation | 15 | |
| Overall Study | COMPLETED | Oxaliplatin/ Gemcitabine Then Radiation | 15 | |
| Overall Study | NOT COMPLETED | Oxaliplatin/ Gemcitabine Then Radiation | 5 |
Source ClinicalTrials.gov
Adverse events122
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 | Abdomen, pain | Gastrointestinal disorders | Oxaliplatin/ Gemcitabine | 0 | 19 | |
| other | Abdomen, pain | Gastrointestinal disorders | Radiation | 3 | 15 | |
| other | Allergic reaction | Immune system disorders | Oxaliplatin/ Gemcitabine | 0 | 19 | |
| other | Allergic reaction | Immune system disorders | Radiation | 1 | 15 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Oxaliplatin/ Gemcitabine | 2 | 19 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Radiation | 0 | 15 | |
| other | ALT, SGPT | Investigations | Oxaliplatin/ Gemcitabine | 1 | 19 | |
| other | ALT, SGPT | Investigations | Radiation | 0 | 15 | |
| other | Anorexia | Metabolism and nutrition disorders | Oxaliplatin/ Gemcitabine | 1 | 19 | |
| other | Anorexia | Metabolism and nutrition disorders | Radiation | 2 | 15 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin/ Gemcitabine | ||
| Total, all-cause mortality | Radiation | ||
| Total, other adverse events | Oxaliplatin/ Gemcitabine | 15 | 19 |
| Total, other adverse events | Radiation | 14 | 15 |
| Total, serious adverse events | Oxaliplatin/ Gemcitabine | 2 | 19 |
| Total, serious adverse events | Radiation | 2 | 15 |
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 |
|---|
| Oxaliplatin/ Gemcitabine vs Radiation: serious adverse events |
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/NCT00476086
GET https://conductscience.org/api/trials/v1/NCT00476086/events?page=2