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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryPathological Complete Response10-16 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.
SecondaryNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugUp to 3 yearsOnly adverse events that are possibly, probably or definitely related to study drug are reported.
SecondaryOverall Survival0-5 yearsMeasured from time of registration to death, or last contact date
SecondaryProgression-free Survival0-3 yearsmeasured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPathological Complete Response10-16 weeks after beginning study treatmentEligible patientsparticipantsNUMBER
SECONDARYNumber of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugUp 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.
ParticipantsNUMBER
SECONDARYOverall Survival0-5 yearseligible patientsmonthsMEDIAN
SECONDARYProgression-free Survival0-3 yearseligible patientsmonthsMEDIAN

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Pathological Complete ResponseChemo Plus RT, Surgery, Chemo26participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoAdult respiratory distress syndrome (ARDS)4Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoAnorexia15Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoCNS cerebrovascular ischemia1Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoCalcium, serum-low (hypocalcemia)2Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoCardiac troponin T (cTnT)1Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoCardiac-ischemia/infarction1Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoChyle or lymph leakage1Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoConfusion1Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study DrugChemo Plus RT, Surgery, ChemoCough1Participants

Participant flow5

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDChemo Plus RT, Surgery, Chemo98
Overall StudyEligibleChemo Plus RT, Surgery, Chemo93
Overall StudyEligible and Began Protocol TherapyChemo Plus RT, Surgery, Chemo93
Overall StudyCOMPLETEDChemo Plus RT, Surgery, Chemo34
Overall StudyNOT COMPLETEDChemo Plus RT, Surgery, Chemo64

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHemoglobinBlood and lymphatic system disordersChemo Plus RT, Surgery, Chemo6793
otherSVT and nodal arrhythmia - Atrial fibrillationCardiac disordersChemo Plus RT, Surgery, Chemo1693
otherSVT and nodal arrhythmia - Sinus tachycardiaCardiac disordersChemo Plus RT, Surgery, Chemo893
otherConstipationGastrointestinal disordersChemo Plus RT, Surgery, Chemo2893
otherDiarrheaGastrointestinal disordersChemo Plus RT, Surgery, Chemo5993
otherDistention/bloating, abdominalGastrointestinal disordersChemo Plus RT, Surgery, Chemo593
otherDysphagia (difficulty swallowing)Gastrointestinal disordersChemo Plus RT, Surgery, Chemo4093
otherEsophagitisGastrointestinal disordersChemo Plus RT, Surgery, Chemo1093
otherGastritis (including bile reflux gastritis)Gastrointestinal disordersChemo Plus RT, Surgery, Chemo593
otherGastrointestinal-Other (Specify)Gastrointestinal disordersChemo Plus RT, Surgery, Chemo893

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityChemo Plus RT, Surgery, Chemo
Total, other adverse eventsChemo Plus RT, Surgery, Chemo9393
Total, serious adverse eventsChemo Plus RT, Surgery, Chemo793

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
22025151DERIVED

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U10CA032102Southwest Oncology Group Treatment GrantBLANKE, CHARLES D.OREGON HEALTH & SCIENCE UNIVERSITYNATIONAL CANCER INSTITUTE1985 to 2013

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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