Trial · NCT00938470
Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
NCT00938470, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction. Trials, record NCT00938470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00938470
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
- NCT number
- NCT00938470
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 73 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer
- Interventions
- capecitabine, docetaxel, fluorouracil, oxaliplatin, radiation therapy, therapeutic conventional surgery
- First posted
- 2009-07-13
- Last updated
- 2018-03-29
- Results first posted
- 2017-04-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Pathologic Complete Response (PCR) | Up to 2 years | Pathologic complete response was defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined. |
| Secondary | Overall Survival | Up to 2 years | Overall survival was defined as the time from randomization to the time of death from any cause. Overall survival was censored at the date of last follow-up visit for patients who are still alive or loss of follow-up. |
| Secondary | Disease-free Survival | Up to 2 years | Disease-free survival was defined as the time from randomization to the date of recurrent or death, whichever comes first. |
| Secondary | Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event | Up to 2 years | Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Secondary | Percentage of Participants With Overall Clinical Tumor Response (CR or PR) | Up to 2 years | Overall clinical tumor response rate was defined as the percentage of evaluable participants who achieved either complete response (CR) or partial response (PR) noted on the objective status from pre-surgical staging (for arm II) or either from pre-RT or pre-surgical staging (for arm I).\> CR was defined as disappearance of all non-target lesion (TL) and normalization of tumor biomarker level, all lymph nodes (LN) must be non-pathological in size (\<1 cm short axis); or disappearance of all TL and normalization of tumor biomarkers, any pathological LN (whether target or non-target) must have reduction in short axis to \<1 cm; or \>=30% decrease in the sum of the diameters of TL taking as reference the baseline sum of the diameters. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Pathologic Complete Response (PCR) | Up to 2 years | Eligible randomized participants who initiated first cycle of protocol treatment. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Up to 2 years | Eligible randomized participants who initiated first cycle of protocol treatment. | months | MEDIAN |
| SECONDARY | Disease-free Survival | Up to 2 years | Eligible randomized participants who initiated first cycle of protocol treatment. | months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event | Up to 2 years | Eligible randomized participants who initiated first cycle of protocol treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Overall Clinical Tumor Response (CR or PR) | Up to 2 years | Eligible randomized participants who initiated first cycle of protocol treatment. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Pathologic Complete Response (PCR) | Arm I (DOC, 5FU/O/RT, Surgery) | 28.6 | 95% Confidence Interval 13.2 to 48.7 | percentage of participants | |
| Percentage of Participants With Pathologic Complete Response (PCR) | Arm II (5FU/O/RT, Surgery) | 40.7 | 95% Confidence Interval 22.4 to 61.2 | percentage of participants | |
| Overall Survival | Arm I (DOC, 5FU/O/RT, Surgery) | NA | 95% Confidence Interval 24.0 to NA | months | |
| Overall Survival | Arm II (5FU/O/RT, Surgery) | 18.8 | 95% Confidence Interval 13.3 to NA | months | |
| Disease-free Survival | Arm I (DOC, 5FU/O/RT, Surgery) | 31.2 | 95% Confidence Interval 15.4 to NA | months | |
| Disease-free Survival | Arm II (5FU/O/RT, Surgery) | 17.0 | 95% Confidence Interval 11.1 to NA | months | |
| Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event | Arm I (DOC, 5FU/O/RT, Surgery) | Grade 3=Severe | 10 | Participants | |
| Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event | Arm II (5FU/O/RT, Surgery) | Grade 3=Severe | 12 | Participants | |
| Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event | Arm I (DOC, 5FU/O/RT, Surgery) | Grade 4=Life threatening | 10 | Participants | |
| Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event | Arm II (5FU/O/RT, Surgery) | Grade 4=Life threatening | 7 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (DOC, 5FU/O/RT, Surgery) | 34 | |
| Overall Study | STARTED | Arm II (5FU/O/RT, Surgery) | 28 | |
| Overall Study | COMPLETED | Arm I (DOC, 5FU/O/RT, Surgery) | 27 | |
| Overall Study | COMPLETED | Arm II (5FU/O/RT, Surgery) | 25 | |
| Overall Study | NOT COMPLETED | Arm I (DOC, 5FU/O/RT, Surgery) | 7 | |
| Overall Study | NOT COMPLETED | Arm II (5FU/O/RT, Surgery) | 3 |
Source ClinicalTrials.gov
Adverse events310
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 | Anemia | Blood and lymphatic system disorders | Arm I (DOC, 5FU/O/RT, Surgery) | 7 | 34 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (5FU/O/RT, Surgery) | 8 | 28 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (DOC, 5FU/O/RT, Surgery) | 1 | 34 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (5FU/O/RT, Surgery) | 0 | 28 | 0 |
| other | Asystole | Cardiac disorders | Arm I (DOC, 5FU/O/RT, Surgery) | 0 | 34 | 0 |
| other | Asystole | Cardiac disorders | Arm II (5FU/O/RT, Surgery) | 1 | 28 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Arm I (DOC, 5FU/O/RT, Surgery) | 4 | 34 | 5 |
| other | Atrial fibrillation | Cardiac disorders | Arm II (5FU/O/RT, Surgery) | 1 | 28 | 1 |
| other | Atrial flutter | Cardiac disorders | Arm I (DOC, 5FU/O/RT, Surgery) | 1 | 34 | 1 |
| other | Atrial flutter | Cardiac disorders | Arm II (5FU/O/RT, Surgery) | 1 | 28 | 1 |
1 to 10 of 310Source ClinicalTrials.gov
See all 310 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (DOC, 5FU/O/RT, Surgery) | ||
| Total, all-cause mortality | Arm II (5FU/O/RT, Surgery) | ||
| Total, other adverse events | Arm I (DOC, 5FU/O/RT, Surgery) | 34 | 34 |
| Total, other adverse events | Arm II (5FU/O/RT, Surgery) | 28 | 28 |
| Total, serious adverse events | Arm I (DOC, 5FU/O/RT, Surgery) | 7 | 34 |
| Total, serious adverse events | Arm II (5FU/O/RT, Surgery) | 7 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33934058 | DERIVED |
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 |
|---|
| Arm I (DOC, 5FU/O/RT, Surgery) vs Arm II (5FU/O/RT, Surgery): 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.
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/NCT00938470
GET https://conductscience.org/api/trials/v1/NCT00938470/events?page=2