Trial · NCT00335959
S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery
NCT00335959, Phase 2, Terminated, SWOG Cancer Research Network; results first posted 2012-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery. Trials, record NCT00335959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00335959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery
- NCT number
- NCT00335959
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Gastric Cancer
- Interventions
- capecitabine, oxaliplatin, conventional surgery, radiation therapy
- First posted
- 2006-06-12
- Last updated
- 2012-08-17
- Results first posted
- 2012-08-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Complete Response | 17-19 weeks | Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor. |
| Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery. | Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery. | Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. | Participants with a given type of AE | NUMBER |
| PRIMARY | Pathologic Complete Response | 17-19 weeks | Eligible patients who completed pre-operative therapy were assessed for response. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
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 Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Anorexia | 1 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Dehydration | 2 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Diarrhea | 2 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Fatigue (asthenia, lethargy, malaise) | 1 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Gastrointestinal-Other (Specify) | 1 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Hemoglobin | 1 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Leukocytes (total WBC) | 1 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Lymphopenia | 2 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Nausea | 1 | Participants with a given type of AE | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemotherapy, Chemoradiation and Surgery | Necrosis, GI - Small bowel NOS | 1 | Participants with a given type of AE |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy, Chemoradiation, Surgery | 7 | |
| Overall Study | Eligible | Chemotherapy, Chemoradiation, Surgery | 6 | |
| Overall Study | Eligible and Began Protocol Therapy | Chemotherapy, Chemoradiation, Surgery | 6 | |
| Overall Study | COMPLETED | Chemotherapy, Chemoradiation, Surgery | 4 | |
| Overall Study | NOT COMPLETED | Chemotherapy, Chemoradiation, Surgery | 3 |
Source ClinicalTrials.gov
Adverse events43
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 | Hemoglobin | Blood and lymphatic system disorders | Chemotherapy, Chemoradiation and Surgery | 4 | 6 | |
| other | Ventricular arrhythmia - PVCs | Cardiac disorders | Chemotherapy, Chemoradiation and Surgery | 1 | 6 | |
| other | Constipation | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 1 | 6 | |
| other | Diarrhea | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 3 | 6 | |
| other | Dysphagia (difficulty swallowing) | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 1 | 6 | |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 1 | 6 | |
| other | Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 1 | 6 | |
| other | Mucositis/stomatitis (functional/symptomatic) - Oral cavity | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 1 | 6 | |
| other | Nausea | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 6 | 6 | |
| other | Necrosis, GI - Small bowel NOS | Gastrointestinal disorders | Chemotherapy, Chemoradiation and Surgery | 1 | 6 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy, Chemoradiation and Surgery | ||
| Total, other adverse events | Chemotherapy, Chemoradiation and Surgery | 6 | 6 |
| Total, serious adverse events | Chemotherapy, Chemoradiation and Surgery | 1 | 6 |
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 |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
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/NCT00335959
GET https://conductscience.org/api/trials/v1/NCT00335959/results?page=2