Trial · NCT00338988
Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
NCT00338988, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2010-12-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma. Trials, record NCT00338988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00338988
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
- NCT number
- NCT00338988
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Cancer of the Gallbladder, Cancer of the Biliary Tract
- Interventions
- Capecitabine, Oxaliplatin
- First posted
- 2006-06-20
- Last updated
- 2012-08-01
- Results first posted
- 2010-12-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response | Baseline with restaging every 3 cycles (cycle=21 days) | Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST \[changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria\]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Objective Response | Baseline with restaging every 3 cycles (cycle=21 days) | Analysis was per protocol. One participant was found ineligible and received no treatment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Response | Capecitabine + Oxaliplatin | 1 | participants |
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 | Capecitabine + Oxaliplatin | 44 | |
| Overall Study | COMPLETED | Capecitabine + Oxaliplatin | 43 | |
| Overall Study | NOT COMPLETED | Capecitabine + Oxaliplatin | 1 |
Source ClinicalTrials.gov
Adverse events60
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 | Abdominal Pain | Gastrointestinal disorders | Stratum: 1 Prior Regimen | 5 | 18 | |
| other | Abdominal Pain | Gastrointestinal disorders | Stratum 2: No Prior Therapy | 11 | 26 | |
| other | Alkaline Phosphatase (increase) | Hepatobiliary disorders | Stratum: 1 Prior Regimen | 2 | 18 | |
| other | Alkaline Phosphatase (increase) | Hepatobiliary disorders | Stratum 2: No Prior Therapy | 5 | 26 | |
| other | Anemia | Blood and lymphatic system disorders | Stratum: 1 Prior Regimen | 2 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Stratum 2: No Prior Therapy | 4 | 26 | |
| other | Anorexia | Gastrointestinal disorders | Stratum: 1 Prior Regimen | 4 | 18 | |
| other | Anorexia | Gastrointestinal disorders | Stratum 2: No Prior Therapy | 14 | 26 | |
| other | Diarrhea | Gastrointestinal disorders | Stratum: 1 Prior Regimen | 8 | 18 | |
| other | Diarrhea | Gastrointestinal disorders | Stratum 2: No Prior Therapy | 14 | 26 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum: 1 Prior Regimen | ||
| Total, all-cause mortality | Stratum 2: No Prior Therapy | ||
| Total, other adverse events | Stratum: 1 Prior Regimen | 18 | 18 |
| Total, other adverse events | Stratum 2: No Prior Therapy | 26 | 26 |
| Total, serious adverse events | Stratum: 1 Prior Regimen | 4 | 18 |
| Total, serious adverse events | Stratum 2: No Prior Therapy | 2 | 26 |
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 |
|---|
| Stratum: 1 Prior Regimen vs Stratum 2: No Prior Therapy: 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/NCT00338988
GET https://conductscience.org/api/trials/v1/NCT00338988/events?page=2