Trial · NCT01196390
Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
NCT01196390, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2021-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer. Trials, record NCT01196390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01196390
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
- NCT number
- NCT01196390
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 203 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Stage IB Esophageal Cancer AJCC v7, Stage IIA Esophageal Cancer AJCC v7, Stage IIB Esophageal Cancer AJCC v7, Stage IIIA Esophageal Cancer AJCC v7, Stage IIIB Esophageal Cancer AJCC v7
- Interventions
- Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Radiation Therapy, Therapeutic Conventional Surgery, Trastuzumab
- First posted
- 2010-09-08
- Last updated
- 2026-06-02
- Results first posted
- 2021-05-04
- Limitations and caveats
Due to a considerable decrease in the overall rate of new disease-free survival events, the NRG Data Monitoring Committee (DMC) determined that the study would not reach the required 162 events in a reasonable amount of time. With power from the observed number of events calculated to be greater than 80%, the DMC recommended releasing the results for reporting.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival (DFS) | From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years. | A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported. |
| Secondary | Percentage of Participants With Pathologic Complete Response at Surgery | At the time of surgery, 5-8 weeks after completion of radiation therapy. | Pathologic Complete Response (pCR) is evaluated after surgery and is based on the pathology review of the submitted surgical specimen. Pathologic Complete Response occurs if the pathologist determines that the resected esophageal specimen, accompanying lymph nodes, and surgical margins are all free of tumor. |
| Secondary | Overall Survival | From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years. | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 109 deaths were reported. |
| Secondary | Frequency of Highest Grade Adverse Event Per Participant | From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years. | Common Terminology Criteria for Adverse Events (version 4.0 before 4-1-2018; then version 5.0) grades adverse event severity from 1=mild to 5=death. Summary data provided is in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Secondary | Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment | Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start | The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer with a total score ranging from 0-68. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). A higher score indicates better QOL. Improvement is defined as an increase from the baseline score of at least 5 points. |
| Secondary | Quality-adjusted Survival | From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years. | |
| Secondary | Molecular Correlates of Efficacy | From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years. | |
| Secondary | Number of Participants With Any Cardiac Adverse Events Regardless of Attribution | From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years. | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event (AE) severity from 1=mild to 5=death. Logistic regression was used to evaluate treatment arm, clinical tumor stage (T stage), Zubrod Performance Status, gender, presence of adenopathy, and age as possible predictors of cardiac adverse events. Results of the final model are reported in the statistical analysis section. Summary adverse event data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Other | Disease-free Survival (DFS) by Sex | From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years. | NIH-required analysis. A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported. |
| Other | Disease-free Survival (DFS) by Ethnicity | From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years. | NIH-required analysis. A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival (DFS) | From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years. | Eligible randomized participants | months | MEDIAN |
| SECONDARY | Percentage of Participants With Pathologic Complete Response at Surgery | At the time of surgery, 5-8 weeks after completion of radiation therapy. | Eligible participants who had surgery | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years. | Eligible randomized participants | months | MEDIAN |
| SECONDARY | Frequency of Highest Grade Adverse Event Per Participant | From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years. | Eligible participants who started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment | Baseline, 6-8 weeks after end of radiation therapy (approximately 11.5-13.5 weeks from treatment start), 1 and 2 years from treatment start | Eligible participants who consented to quality of life evaluation and who had baseline and time point data. | percentage of participants | NUMBER |
| SECONDARY | Quality-adjusted Survival | From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years. | The protocol states that this outcome measure will be analyzed only if primary outcome results are positive, i.e. support the primary hypothesis of this study. Therefore no participants were analyzed for this outcome measure. | ||
| SECONDARY | Molecular Correlates of Efficacy | From randomization to last follow-up. Maximum follow-up at time of primary outcome measure analysis was 8 years. | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | ||
| SECONDARY | Number of Participants With Any Cardiac Adverse Events Regardless of Attribution | From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years. | Eligible participants who started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Disease-free Survival (DFS) by Sex | From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years. | Eligible randomized participants. Data were stratified by sex. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Disease-free Survival (DFS) by Ethnicity | From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years. | Eligible randomized participants. Data were stratified by ethnicity. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival (DFS) | Chemoradiation and Trastuzumab (Arm 1) | 19.6 | 95% Confidence Interval 13.5 to 26.2 | months | |
| Disease-free Survival (DFS) | Chemoradiation (Arm 2) | 14.2 | 95% Confidence Interval 10.5 to 23.0 | months | |
| Percentage of Participants With Pathologic Complete Response at Surgery | Chemoradiation and Trastuzumab | 27 | 95% Confidence Interval 18 to 38 | percentage of participants | |
| Percentage of Participants With Pathologic Complete Response at Surgery | Chemoradiation | 29 | 95% Confidence Interval 20 to 41 | percentage of participants | |
| Overall Survival | Chemoradiation and Trastuzumab | 38.5 | 95% Confidence Interval 26.2 to 70.4 | months | |
| Overall Survival | Chemoradiation | 38.9 | 95% Confidence Interval 29.0 to 64.5 | months | |
| Frequency of Highest Grade Adverse Event Per Participant | Chemoradiation and Trastuzumab | All Adverse Events / Grade 1 | 0 | Participants | |
| Frequency of Highest Grade Adverse Event Per Participant | Chemoradiation | All Adverse Events / Grade 1 | 0 | Participants | |
| Frequency of Highest Grade Adverse Event Per Participant | Chemoradiation and Trastuzumab | All Adverse Events / Grade 2 | 14 | Participants | |
| Frequency of Highest Grade Adverse Event Per Participant | Chemoradiation | All Adverse Events / Grade 2 | 12 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemoradiation and Trastuzumab | 102 | |
| Overall Study | STARTED | Chemoradiation | 101 | |
| Overall Study | Eligible | Chemoradiation and Trastuzumab | 98 | |
| Overall Study | Eligible | Chemoradiation | 96 | |
| Overall Study | Eligible and Started Study Treatment | Chemoradiation and Trastuzumab | 95 | |
| Overall Study | Eligible and Started Study Treatment | Chemoradiation | 96 | |
| Overall Study | Eligible and Had Surgery | Chemoradiation and Trastuzumab | 82 | |
| Overall Study | Eligible and Had Surgery | Chemoradiation | 78 | |
| Overall Study | Eligible and Consented to Quality of Life Component | Chemoradiation and Trastuzumab | 88 | |
| Overall Study | Eligible and Consented to Quality of Life Component | Chemoradiation | 83 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events392
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 | Chemoradiation and Trastuzumab | 61 | 95 | |
| other | Anemia | Blood and lymphatic system disorders | Chemoradiation | 57 | 96 | |
| other | Atrial fibrillation | Cardiac disorders | Chemoradiation and Trastuzumab | 5 | 95 | |
| other | Atrial fibrillation | Cardiac disorders | Chemoradiation | 3 | 96 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Chemoradiation and Trastuzumab | 3 | 95 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Chemoradiation | 5 | 96 | |
| other | Sinus tachycardia | Cardiac disorders | Chemoradiation and Trastuzumab | 6 | 95 | |
| other | Sinus tachycardia | Cardiac disorders | Chemoradiation | 9 | 96 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemoradiation and Trastuzumab | 28 | 95 | |
| other | Abdominal pain | Gastrointestinal disorders | Chemoradiation | 31 | 96 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemoradiation and Trastuzumab | 53 | 95 |
| Total, all-cause mortality | Chemoradiation | 55 | 96 |
| Total, other adverse events | Chemoradiation and Trastuzumab | 95 | 95 |
| Total, other adverse events | Chemoradiation | 96 | 96 |
| Total, serious adverse events | Chemoradiation and Trastuzumab | 51 | 95 |
| Total, serious adverse events | Chemoradiation | 34 | 96 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35038433 | DERIVED |
Source PubMed
Grants3
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA180830 | NCI NCTN- Network Lead Academic Participating Site: USC | LENZ, HEINZ JOSEF; EL-KHOUEIRY, ANTHONY BOUTROS; QUINN, DAVID IAN | UNIVERSITY OF SOUTHERN CALIFORNIA | NATIONAL CANCER INSTITUTE | 2014 to 2018 | NIH RePORTER |
| U10CA021661 | Radiation Therapy Oncology Group | CURRAN, WALTER J. | AMERICAN COLLEGE OF RADIOLOGY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemoradiation and Trastuzumab (Arm 1) vs Chemoradiation (Arm 2): Number of Participants With Any Cardiac Adverse Events Regardless of Attribution | Trial comparisons |
| Chemoradiation and Trastuzumab vs Chemoradiation: deaths from any cause | Trial comparisons |
| Chemoradiation and Trastuzumab vs Chemoradiation: 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.
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