Trial · NCT00514020
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
NCT00514020, Phase 2, Completed, Vanderbilt-Ingram Cancer Center; results first posted 2012-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer. Trials, record NCT00514020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00514020
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
- NCT number
- NCT00514020
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Gastric Cancer
- Interventions
- fluorouracil, leucovorin calcium, oxaliplatin, gene expression analysis, polymorphism analysis, protein expression analysis, pharmacological study
- First posted
- 2007-08-09
- Last updated
- 2012-11-01
- Results first posted
- 2012-10-18
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 Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression]) | every 8 weeks to progression | Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment. |
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 Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression]) | every 8 weeks to progression | Patients available for measurement of response. All patients who received Oxaliplatin + Leucovorin + 5-Fluorouracil are in the heterozygous good risk genotype group. One patient was not evaluable for response. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression]) | Oxaliplatin + Leucovorin + 5-Fluorouracil | Complete Response | 0 | participants | |
| Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression]) | Oxaliplatin + Leucovorin + 5-Fluorouracil | Partial Response | 9 | participants | |
| Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression]) | Oxaliplatin + Leucovorin + 5-Fluorouracil | Progressive Disease | 1 | participants | |
| Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression]) | Oxaliplatin + Leucovorin + 5-Fluorouracil | Stable Disease | 14 | 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 | 5-FU, Leucovorin, Oxaliplatin | 33 | |
| Overall Study | COMPLETED | 5-FU, Leucovorin, Oxaliplatin | 5 | |
| Overall Study | NOT COMPLETED | 5-FU, Leucovorin, Oxaliplatin | 28 |
Source ClinicalTrials.gov
Adverse events59
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 | albumin, serum-low | Metabolism and nutrition disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 17 | 24 | 29 |
| other | alkaline phosphatase | Investigations | Oxaliplatin + Leucovorin + 5-Fluorouracil | 10 | 24 | 13 |
| other | ALT/SGPT (serum glutamine pyruvic transminase) | Investigations | Oxaliplatin + Leucovorin + 5-Fluorouracil | 11 | 24 | 15 |
| other | anorexia | Metabolism and nutrition disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 8 | 24 | 8 |
| other | ascites (non-malignant) | Gastrointestinal disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 3 | 24 | 4 |
| other | AST, SGOT (serum glutamine oxaloacetic transminase) | Investigations | Oxaliplatin + Leucovorin + 5-Fluorouracil | 11 | 24 | 13 |
| other | bilirubin (hyperbilirubinemia) | Hepatobiliary disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 2 | 24 | 3 |
| other | calcium, serum-low-hypocalcemia | Metabolism and nutrition disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 10 | 24 | 14 |
| other | constipation | Gastrointestinal disorders | Oxaliplatin + Leucovorin + 5-Fluorouracil | 7 | 24 | 11 |
| other | creatine | Investigations | Oxaliplatin + Leucovorin + 5-Fluorouracil | 2 | 24 | 3 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxaliplatin + Leucovorin + 5-Fluorouracil | ||
| Total, other adverse events | Oxaliplatin + Leucovorin + 5-Fluorouracil | 24 | 24 |
| Total, serious adverse events | Oxaliplatin + Leucovorin + 5-Fluorouracil | 14 | 24 |
Source ClinicalTrials.gov
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA068485 | Cancer Center Support Grant | PARK, BEN HO | VANDERBILT UNIVERSITY MEDICAL CENTER | NATIONAL CANCER INSTITUTE | 1995 to 2025 |
Source NIH RePORTER
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/NCT00514020
GET https://conductscience.org/api/trials/v1/NCT00514020/events?page=2