Trial · NCT00354887
Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater
NCT00354887, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2011-07-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater. Trials, record NCT00354887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00354887
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater
- NCT number
- NCT00354887
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Gastrointestinal Cancer
- Interventions
- Capecitabine, Oxaliplatin
- First posted
- 2006-07-20
- Last updated
- 2012-10-29
- Results first posted
- 2011-07-14
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 Overall Response | Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses | Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR. |
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 Overall Response | Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses | Analysis was intent-to-treat; One patient developed an acute flare of Crohn's disease after one cycle of study treatment and was removed from study without undergoing restaging scans. | 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 |
|---|---|---|---|---|---|
| Number of Participants With Overall Response | Oxaliplatin + Capecitabine | Participants with CR | 3 | participants | |
| Number of Participants With Overall Response | Oxaliplatin + Capecitabine | Participants with PR | 12 | 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 | Oxaliplatin + Capecitabine | 30 | |
| Overall Study | COMPLETED | Oxaliplatin + Capecitabine | 29 | |
| Overall Study | NOT COMPLETED | Oxaliplatin + Capecitabine | 1 |
Source ClinicalTrials.gov
Adverse events63
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 | Oxaliplatin + Capecitabine | 12 | 30 | |
| other | Abdominal bloating | Gastrointestinal disorders | Oxaliplatin + Capecitabine | 3 | 30 | |
| other | Alkaline Phosphatase | Metabolism and nutrition disorders | Oxaliplatin + Capecitabine | 9 | 30 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Oxaliplatin + Capecitabine | 6 | 30 | |
| other | Anorexia | Gastrointestinal disorders | Oxaliplatin + Capecitabine | 17 | 30 | |
| other | Belching | Gastrointestinal disorders | Oxaliplatin + Capecitabine | 2 | 30 | |
| other | Bilirubin | Metabolism and nutrition disorders | Oxaliplatin + Capecitabine | 4 | 30 | |
| other | Chest Pain | Cardiac disorders | Oxaliplatin + Capecitabine | 2 | 30 | |
| other | Cold Intolerance | General disorders | Oxaliplatin + Capecitabine | 2 | 30 | |
| other | Constipation | Gastrointestinal disorders | Oxaliplatin + Capecitabine | 16 | 30 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin + Capecitabine | ||
| Total, other adverse events | Oxaliplatin + Capecitabine | 30 | 30 |
| Total, serious adverse events | Oxaliplatin + Capecitabine | 0 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19164203 | RESULT |
Source PubMed
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/NCT00354887
GET https://conductscience.org/api/trials/v1/NCT00354887/events?page=2