Trial · NCT00052910
Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer
NCT00052910, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2018-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer. Trials, record NCT00052910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00052910
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer
- NCT number
- NCT00052910
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 546 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Esophageal Cancer, Gastric Cancer
- Interventions
- cisplatin, epirubicin hydrochloride, fluorouracil, leucovorin calcium, radiation therapy
- First posted
- 2003-01-27
- Last updated
- 2020-05-07
- Results first posted
- 2018-07-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From study enrollment until death from any cause; up to 3 years | Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. |
| Secondary | Disease Free Survival | From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years | Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From study enrollment until death from any cause; up to 3 years | years | MEDIAN | |
| SECONDARY | Disease Free Survival | From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years | years | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm I (5-FU/LV) | 3.6 | 95% Confidence Interval 2.8 to 4.9 | years | |
| Overall Survival | Arm II (ECF) | 3.5 | 95% Confidence Interval 2.5 to 5.0 | years | |
| Disease Free Survival | Arm I (5-FU/LV) | 2.7 | 95% Confidence Interval 1.9 to 3.8 | years | |
| Disease Free Survival | Arm II (ECF) | 2.3 | 95% Confidence Interval 1.5 to 3.1 | years |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (5-FU/LV) | 280 | |
| Overall Study | STARTED | Arm II (ECF) | 266 | |
| Overall Study | COMPLETED | Arm I (5-FU/LV) | 280 | |
| Overall Study | COMPLETED | Arm II (ECF) | 266 | |
| Overall Study | NOT COMPLETED | Arm I (5-FU/LV) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (ECF) | 0 |
Source ClinicalTrials.gov
Adverse events758
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 | Blood disorder | Blood and lymphatic system disorders | Arm I (5-FU/LV) | 2 | 272 | 4 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm II (ECF) | 1 | 251 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (5-FU/LV) | 10 | 272 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (ECF) | 8 | 251 | 10 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (5-FU/LV) | 80 | 272 | 165 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (ECF) | 81 | 251 | 180 |
| other | Hemoglobin for leukemia studies | Blood and lymphatic system disorders | Arm I (5-FU/LV) | 0 | 272 | 0 |
| other | Hemoglobin for leukemia studies | Blood and lymphatic system disorders | Arm II (ECF) | 2 | 251 | 2 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (5-FU/LV) | 2 | 272 | 2 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (ECF) | 1 | 251 | 1 |
1 to 10 of 758Source ClinicalTrials.gov
See all 758 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (5-FU/LV) | 11 | 272 |
| Total, all-cause mortality | Arm II (ECF) | 5 | 251 |
| Total, other adverse events | Arm I (5-FU/LV) | 258 | 272 |
| Total, other adverse events | Arm II (ECF) | 234 | 251 |
| Total, serious adverse events | Arm I (5-FU/LV) | 62 | 272 |
| Total, serious adverse events | Arm II (ECF) | 42 | 251 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34149004 | 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 |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (5-FU/LV) vs Arm II (ECF): deaths from any cause | Trial comparisons |
| Arm I (5-FU/LV) vs Arm II (ECF): serious adverse events | 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/NCT00052910
GET https://conductscience.org/api/trials/v1/NCT00052910/events?page=2