Trial · NCT00033657
Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
NCT00033657, Phase 2, Completed, Eastern Cooperative Oncology Group; results first posted 2011-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer. Trials, record NCT00033657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00033657
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
- NCT number
- NCT00033657
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Esophageal Cancer, Gastric Cancer
- Interventions
- cisplatin, irinotecan hydrochloride, paclitaxel, conventional surgery, radiation therapy
- First posted
- 2003-01-27
- Last updated
- 2023-06-28
- Results first posted
- 2011-07-19
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 | approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue. |
| Secondary | Overall Survival Time | Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients. |
| Secondary | Recurrence-free Survival Time | Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients. |
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 | approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | Eligible, treated patients | percentage of participants | NUMBER |
| SECONDARY | Overall Survival Time | Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | Eligible, treated patients | Months | MEDIAN |
| SECONDARY | Recurrence-free Survival Time | Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Complete Response Rate | Cisplatin / Irinotecan / RT (Arm A) | 15.4 | 90% Confidence Interval 6.9 to 28.1 | percentage of participants | |
| Pathologic Complete Response Rate | Paclitaxel / Cisplatin / RT (Arm B) | 16.7 | 90% Confidence Interval 8.1 to 29.0 | percentage of participants | |
| Overall Survival Time | Cisplatin / Irinotecan / RT (Arm A) | 35.0 | 95% Confidence Interval 19.5 to 67.7 | Months | |
| Overall Survival Time | Paclitaxel / Cisplatin / RT (Arm B) | 21.0 | 95% Confidence Interval 17.4 to 49.3 | Months | |
| Recurrence-free Survival Time | Cisplatin / Irinotecan / RT (Arm A) | 39.8 | 95% Confidence Interval 13.3 to NA | Months | |
| Recurrence-free Survival Time | Paclitaxel / Cisplatin / RT (Arm B) | 12.4 | 95% Confidence Interval 11.0 to 31.4 | Months |
Source ClinicalTrials.gov
Participant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Neoadjuvant Chemotherapy | STARTED | Cisplatin / Irinotecan / RT (Arm A) | 50 | |
| Neoadjuvant Chemotherapy | STARTED | Paclitaxel / Cisplatin / RT (Arm B) | 47 | |
| Neoadjuvant Chemotherapy | Eligible | Cisplatin / Irinotecan / RT (Arm A) | 42 | |
| Neoadjuvant Chemotherapy | Eligible | Paclitaxel / Cisplatin / RT (Arm B) | 43 | |
| Neoadjuvant Chemotherapy | Eligible and Treated | Cisplatin / Irinotecan / RT (Arm A) | 39 | |
| Neoadjuvant Chemotherapy | Eligible and Treated | Paclitaxel / Cisplatin / RT (Arm B) | 42 | |
| Neoadjuvant Chemotherapy | COMPLETED | Cisplatin / Irinotecan / RT (Arm A) | 36 | |
| Neoadjuvant Chemotherapy | COMPLETED | Paclitaxel / Cisplatin / RT (Arm B) | 36 | |
| Neoadjuvant Chemotherapy | NOT COMPLETED | Cisplatin / Irinotecan / RT (Arm A) | 14 | |
| Neoadjuvant Chemotherapy | NOT COMPLETED | Paclitaxel / Cisplatin / RT (Arm B) | 11 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events380
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 | Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | 38 | 47 | |
| other | Anemia | Blood and lymphatic system disorders | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | 40 | 46 | |
| other | Anemia | Blood and lymphatic system disorders | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | 28 | 31 | |
| other | Anemia | Blood and lymphatic system disorders | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | 22 | 27 | |
| other | Leukopenia | Investigations | Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | 44 | 47 | |
| other | Leukopenia | Investigations | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | 41 | 46 | |
| other | Leukopenia | Investigations | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | 27 | 31 | |
| other | Leukopenia | Investigations | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | 17 | 27 | |
| other | Neutropenia | Investigations | Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | 35 | 47 | |
| other | Neutropenia | Investigations | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | 24 | 46 |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | ||
| Total, all-cause mortality | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | ||
| Total, all-cause mortality | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | ||
| Total, all-cause mortality | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | ||
| Total, other adverse events | Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | 47 | 47 |
| Total, other adverse events | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | 46 | 46 |
| Total, other adverse events | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | 30 | 31 |
| Total, other adverse events | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | 25 | 27 |
| Total, serious adverse events | Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | 32 | 47 |
| Total, serious adverse events | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | 30 | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | 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/NCT00033657
GET https://conductscience.org/api/trials/v1/NCT00033657/flow?page=2