Trial · NCT00678535
Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
NCT00678535, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2013-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer. Trials, record NCT00678535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00678535
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
- NCT number
- NCT00678535
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 904 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Gastric Cancer
- Interventions
- Cetuximab, Capecitabine, Cisplatin
- First posted
- 2008-05-15
- Last updated
- 2014-07-21
- Other registries' IDs
- eudract:2007-004219-75
- Results first posted
- 2013-05-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment. |
| Secondary | Overall Survival (OS) | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012) | The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. |
| Secondary | Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments | Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012) | The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors \[RECIST\] Version 1.0) from the IRC. |
| Secondary | Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. |
| Secondary | Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire | Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL. |
| Secondary | Safety - Number of Participants With Adverse Events (AEs) | Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | Intent-to-treat (ITT) population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012) | ITT population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments | Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012) | ITT population included all participants who were randomized to trial treatment. | percentage of participants | NUMBER |
| SECONDARY | Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire | Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Safety - Number of Participants With Adverse Events (AEs) | Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012) | The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments | Cetuximab Plus Capecitabine Plus Cisplatin | 4.4 | 95% Confidence Interval 4.2 to 5.5 | months | |
| Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments | Capecitabine Plus Cisplatin | 5.6 | 95% Confidence Interval 5.1 to 5.7 | months | |
| Overall Survival (OS) | Cetuximab Plus Capecitabine Plus Cisplatin | 9.4 | 95% Confidence Interval 8.3 to 10.6 | months | |
| Overall Survival (OS) | Capecitabine Plus Cisplatin | 10.7 | 95% Confidence Interval 9.4 to 11.3 | months | |
| Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments | Cetuximab Plus Capecitabine Plus Cisplatin | 29.9 | 95% Confidence Interval 25.7 to 34.3 | percentage of participants | |
| Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments | Capecitabine Plus Cisplatin | 29.2 | 95% Confidence Interval 25.0 to 33.6 | percentage of participants | |
| Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cetuximab Plus Capecitabine Plus Cisplatin | Global health status: Baseline | 57.49 | Standard Deviation 22.168 | units on a scale |
| Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Capecitabine Plus Cisplatin | Global health status: Baseline | 57.19 | Standard Deviation 22.124 | units on a scale |
| Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Cetuximab Plus Capecitabine Plus Cisplatin | Global health status: Week 6 | 59.00 | Standard Deviation 21.879 | units on a scale |
| Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Capecitabine Plus Cisplatin | Global health status: Week 6 | 61.80 | Standard Deviation 22.089 | units on a scale |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab Plus Capecitabine Plus Cisplatin | 455 | |
| Overall Study | STARTED | Capecitabine Plus Cisplatin | 449 | |
| Overall Study | COMPLETED | Cetuximab Plus Capecitabine Plus Cisplatin | 362 | |
| Overall Study | COMPLETED | Capecitabine Plus Cisplatin | 351 | |
| Overall Study | NOT COMPLETED | Cetuximab Plus Capecitabine Plus Cisplatin | 93 | |
| Overall Study | NOT COMPLETED | Capecitabine Plus Cisplatin | 98 |
Source ClinicalTrials.gov
Adverse events584
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 | Cetuximab Plus Capecitabine Plus Cisplatin | 194 | 446 | |
| other | Neutropenia | Blood and lymphatic system disorders | Capecitabine Plus Cisplatin | 234 | 436 | |
| other | Anaemia | Blood and lymphatic system disorders | Cetuximab Plus Capecitabine Plus Cisplatin | 127 | 446 | |
| other | Anaemia | Blood and lymphatic system disorders | Capecitabine Plus Cisplatin | 155 | 436 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cetuximab Plus Capecitabine Plus Cisplatin | 81 | 446 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Capecitabine Plus Cisplatin | 89 | 436 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cetuximab Plus Capecitabine Plus Cisplatin | 67 | 446 | |
| other | Leukopenia | Blood and lymphatic system disorders | Capecitabine Plus Cisplatin | 94 | 436 | |
| other | Tinnitus | Ear and labyrinth disorders | Cetuximab Plus Capecitabine Plus Cisplatin | 20 | 446 | |
| other | Tinnitus | Ear and labyrinth disorders | Capecitabine Plus Cisplatin | 23 | 436 |
1 to 10 of 584Source ClinicalTrials.gov
See all 584 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab Plus Capecitabine Plus Cisplatin | ||
| Total, all-cause mortality | Capecitabine Plus Cisplatin | ||
| Total, other adverse events | Cetuximab Plus Capecitabine Plus Cisplatin | 441 | 446 |
| Total, other adverse events | Capecitabine Plus Cisplatin | 429 | 436 |
| Total, serious adverse events | Cetuximab Plus Capecitabine Plus Cisplatin | 239 | 446 |
| Total, serious adverse events | Capecitabine Plus Cisplatin | 194 | 436 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cetuximab Plus Capecitabine Plus Cisplatin vs Capecitabine Plus Cisplatin: Safety - Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Cetuximab Plus Capecitabine Plus Cisplatin vs Capecitabine Plus Cisplatin: 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/NCT00678535
GET https://conductscience.org/api/trials/v1/NCT00678535/results?page=2