Trial · NCT00215644
Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
NCT00215644, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer. Trials, record NCT00215644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00215644
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Matuzumab Treatment With Epirubicin, Cisplatin and Capecitabine (ECX) in Esophago-Gastric Cancer
- NCT number
- NCT00215644
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Esophageal Cancer, Gastric Cancer
- Interventions
- Matuzumab, Epirubicin, Cisplatin, Capecitabine
- First posted
- 2005-09-22
- Last updated
- 2018-11-02
- Other registries' IDs
- eudract:2005-000146-36
- Results first posted
- 2018-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response Assessed by Independent Review Committee | Baseline up to PD or death due to any cause (up to approximately 3 years) | Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (\>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. |
| Secondary | Duration of Objective Response Assessed by Independent Review Committee | From first documented objective response to PD or death due to any cause (up to approximately 3 years) | Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: \>50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (PD: \>25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis. |
| Secondary | Progression-Free Survival | Baseline up to PD or death due to any cause (up to approximately 3 years) | PFS was defined as the time from randomization to the first documentation of PD or to death due to any cause, whichever occurred first. PD: \>25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis. |
| Secondary | Overall Survival (OS) | Baseline until death due to any cause (up to approximately 3 years) | OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis. |
| Secondary | Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score | Baseline (Day 1), Post Baseline (Up to 3 Years) | EORTC QLQ-C30 included GHS/QoL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from EORTC QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL was linearly transformed and ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). EORTC QLQ-C30 GHS/QoL score at baseline and best overall change from baseline (throughout study) are reported. |
| Secondary | Protein Biomarkers Levels | Baseline up to approximately 3 years | |
| Secondary | Percentage of Participants With Anti-Matuzumab Antibodies | Baseline up to approximately 3 years | |
| Secondary | Matuzumab Serum Concentration | Baseline up to approximately 3 years |
Source ClinicalTrials.gov
Outcomes8
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 Objective Response Assessed by Independent Review Committee | Baseline up to PD or death due to any cause (up to approximately 3 years) | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response Assessed by Independent Review Committee | From first documented objective response to PD or death due to any cause (up to approximately 3 years) | ITT population. | months | MEDIAN |
| SECONDARY | Progression-Free Survival | Baseline up to PD or death due to any cause (up to approximately 3 years) | ITT population. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline until death due to any cause (up to approximately 3 years) | ITT population. | months | MEDIAN |
| SECONDARY | Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score | Baseline (Day 1), Post Baseline (Up to 3 Years) | ITT population. Here, overall number of participants analyzed = participants who were evaluable for this outcome and Number analyzed = participants evaluable for specified timepoint for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Protein Biomarkers Levels | Baseline up to approximately 3 years | Data for this outcome was not collected from any of the participant; hence, no data available for reporting. | ||
| SECONDARY | Percentage of Participants With Anti-Matuzumab Antibodies | Baseline up to approximately 3 years | Data for this outcome was not collected from any of the participant; hence, no data available for reporting. | ||
| SECONDARY | Matuzumab Serum Concentration | Baseline up to approximately 3 years | Data for this outcome was not collected from any of the participant; hence, no data available for reporting. |
Source ClinicalTrials.gov
Results by group12
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 Objective Response Assessed by Independent Review Committee | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 31 | 95% Confidence Interval 17 to 49 | percentage of participants | |
| Percentage of Participants With Objective Response Assessed by Independent Review Committee | ECX Only | 58 | 95% Confidence Interval 41 to 74 | percentage of participants | |
| Duration of Objective Response Assessed by Independent Review Committee | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | NA | 95% Confidence Interval NA to NA | months | |
| Duration of Objective Response Assessed by Independent Review Committee | ECX Only | NA | 95% Confidence Interval NA to NA | months | |
| Progression-Free Survival | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 4.8 | 95% Confidence Interval 2.9 to 8.1 | months | |
| Progression-Free Survival | ECX Only | 7.1 | 95% Confidence Interval 4.4 to 8.5 | months | |
| Overall Survival (OS) | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 9.4 | 95% Confidence Interval 7.5 to 16.2 | months | |
| Overall Survival (OS) | ECX Only | 12.2 | 95% Confidence Interval 9.8 to 13.8 | months | |
Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | Baseline | 53.3 | Standard Deviation 27.3 | units on a scale |
Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score | ECX Only | Baseline | 67.9 | Standard Deviation 22.4 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 36 | |
| Overall Study | STARTED | ECX Only | 36 | |
| Overall Study | Treated | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 35 | |
| Overall Study | Treated | ECX Only | 36 | |
| Overall Study | COMPLETED | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 0 | |
| Overall Study | COMPLETED | ECX Only | 0 | |
| Overall Study | NOT COMPLETED | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 36 | |
| Overall Study | NOT COMPLETED | ECX Only | 36 |
Source ClinicalTrials.gov
Adverse events30
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 | Neutropenia | Blood and lymphatic system disorders | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 13 | 35 | |
| other | Neutropenia | Blood and lymphatic system disorders | ECX Only | 12 | 36 | |
| other | Anaemia | Blood and lymphatic system disorders | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 2 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | ECX Only | 2 | 36 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 1 | 35 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | ECX Only | 2 | 36 | |
| other | Fatigue/lethargy | General disorders | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 7 | 35 | |
| other | Fatigue/lethargy | General disorders | ECX Only | 5 | 36 | |
| other | Nausea | Gastrointestinal disorders | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 4 | 35 | |
| other | Nausea | Gastrointestinal disorders | ECX Only | 1 | 36 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | ||
| Total, all-cause mortality | ECX Only | ||
| Total, other adverse events | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 35 | 35 |
| Total, other adverse events | ECX Only | 36 | 36 |
| Total, serious adverse events | Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab | 0 | 35 |
| Total, serious adverse events | ECX Only | 0 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20497967 | 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 |
|---|
| Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab vs ECX Only: 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/NCT00215644
GET https://conductscience.org/api/trials/v1/NCT00215644/events?page=2