Trial · NCT00086996
S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
NCT00086996, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2012-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction. Trials, record NCT00086996. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086996
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
- NCT number
- NCT00086996
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 98 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Esophageal Cancer
- Interventions
- fluorouracil, oxaliplatin, conventional surgery, radiation therapy
- First posted
- 2004-07-12
- Last updated
- 2013-10-11
- Results first posted
- 2012-04-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Complete Response | 10-16 weeks after beginning study treatment | Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded. |
| Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 3 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Secondary | Overall Survival | 0-5 years | Measured from time of registration to death, or last contact date |
| Secondary | Progression-free Survival | 0-3 years | measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathological Complete Response | 10-16 weeks after beginning study treatment | Eligible patients | participants | NUMBER |
| SECONDARY | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Up to 3 years | Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any Common Terminology Criteria for Adverse Events (CTCAE) v3.0 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 | NUMBER |
| SECONDARY | Overall Survival | 0-5 years | eligible patients | months | MEDIAN |
| SECONDARY | Progression-free Survival | 0-3 years | eligible patients | months | MEDIAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathological Complete Response | Chemo Plus RT, Surgery, Chemo | 26 | participants | ||
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Adult respiratory distress syndrome (ARDS) | 4 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Anorexia | 15 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | CNS cerebrovascular ischemia | 1 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Calcium, serum-low (hypocalcemia) | 2 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Cardiac troponin T (cTnT) | 1 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Cardiac-ischemia/infarction | 1 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Chyle or lymph leakage | 1 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Confusion | 1 | Participants | |
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Chemo Plus RT, Surgery, Chemo | Cough | 1 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemo Plus RT, Surgery, Chemo | 98 | |
| Overall Study | Eligible | Chemo Plus RT, Surgery, Chemo | 93 | |
| Overall Study | Eligible and Began Protocol Therapy | Chemo Plus RT, Surgery, Chemo | 93 | |
| Overall Study | COMPLETED | Chemo Plus RT, Surgery, Chemo | 34 | |
| Overall Study | NOT COMPLETED | Chemo Plus RT, Surgery, Chemo | 64 |
Source ClinicalTrials.gov
Adverse events78
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 | Chemo Plus RT, Surgery, Chemo | 67 | 93 | |
| other | SVT and nodal arrhythmia - Atrial fibrillation | Cardiac disorders | Chemo Plus RT, Surgery, Chemo | 16 | 93 | |
| other | SVT and nodal arrhythmia - Sinus tachycardia | Cardiac disorders | Chemo Plus RT, Surgery, Chemo | 8 | 93 | |
| other | Constipation | Gastrointestinal disorders | Chemo Plus RT, Surgery, Chemo | 28 | 93 | |
| other | Diarrhea | Gastrointestinal disorders | Chemo Plus RT, Surgery, Chemo | 59 | 93 | |
| other | Distention/bloating, abdominal | Gastrointestinal disorders | Chemo Plus RT, Surgery, Chemo | 5 | 93 | |
| other | Dysphagia (difficulty swallowing) | Gastrointestinal disorders | Chemo Plus RT, Surgery, Chemo | 40 | 93 | |
| other | Esophagitis | Gastrointestinal disorders | Chemo Plus RT, Surgery, Chemo | 10 | 93 | |
| other | Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | Chemo Plus RT, Surgery, Chemo | 5 | 93 | |
| other | Gastrointestinal-Other (Specify) | Gastrointestinal disorders | Chemo Plus RT, Surgery, Chemo | 8 | 93 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemo Plus RT, Surgery, Chemo | ||
| Total, other adverse events | Chemo Plus RT, Surgery, Chemo | 93 | 93 |
| Total, serious adverse events | Chemo Plus RT, Surgery, Chemo | 7 | 93 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22025151 | DERIVED |
Source PubMed
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/NCT00086996
GET https://conductscience.org/api/trials/v1/NCT00086996/results?page=2