Trial · NCT00193128

Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

NCT00193128, Phase 1, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2013-05-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer. Trials, record NCT00193128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00193128

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
NCT number: NCT00193128
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 59 participants, actual
Lead sponsor: SCRI Development Innovations, LLC
Conditions: Esophagus Cancer
Interventions: Oxaliplatin, Docetaxel, Capecitabine, Radiation therapy
First posted: 2005-09-19
Last updated: 2021-11-24
Results first posted: 2013-05-13

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery	18 months	The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
Secondary	Disease-Free Survival (DFS)	18 months	Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
Secondary	Overall Survival (OS)	36 months	Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery	18 months	Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease-Free Survival (DFS)	18 months	Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy	months	MEDIAN
SECONDARY	Overall Survival (OS)	36 months	Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy	months	MEDIAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	24		Participants
Disease-Free Survival (DFS)	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	16.3	95% Confidence Interval 4.5 to 31.5	months
Overall Survival (OS)	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	24.1	95% Confidence Interval 11.4 to 36	months

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	10
Overall Study	STARTED	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	49
Overall Study	COMPLETED	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	10
Overall Study	COMPLETED	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	39
Overall Study	NOT COMPLETED	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	0
Overall Study	NOT COMPLETED	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	10

Source ClinicalTrials.gov

Adverse events140

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	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	3	10	6
other	Hemoglobin	Blood and lymphatic system disorders	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	19	49	51
other	Anorexia	Gastrointestinal disorders	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	5	10	12
other	Anorexia	Gastrointestinal disorders	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	23	49	101
other	Adult Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	1	10	1
other	Adult Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	3	49	6
other	Pain - joint	General disorders	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	1	10	1
other	Pain - joint	General disorders	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	0	49	0
other	Cold intolerance	General disorders	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	2	10	6
other	Cold intolerance	General disorders	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	3	49	9

1 to 10 of 140Source ClinicalTrials.gov

See all 140 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxaliplatin/Docetaxel/Radiation (Cohort 1)
Total, all-cause mortality	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
Total, other adverse events	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	10	10
Total, other adverse events	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	49	49
Total, serious adverse events	Oxaliplatin/Docetaxel/Radiation (Cohort 1)	2	10
Total, serious adverse events	Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)	33	49

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20351330	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Oxaliplatin/Docetaxel/Radiation (Cohort 1) vs Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2): serious adverse events

Source Trial comparisons

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/NCT00193128

GET https://conductscience.org/api/trials/v1/NCT00193128/events?page=2

API reference For AI assistants