Trial · NCT01388790
Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer
NCT01388790, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2013-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer. Trials, record NCT01388790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01388790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer
- NCT number
- NCT01388790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Gastric Cancer
- Interventions
- Cetuximab, Cisplatin, S-1
- First posted
- 2011-07-07
- Last updated
- 2013-11-20
- Results first posted
- 2013-11-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments | Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012) | The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 \[RECIST v 1.0\] criteria). |
| Secondary | Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments | Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012) | The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment. |
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 | Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments | Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012) | ITT population included all participants who received at least one dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments | Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012) | ITT population included all participants who received at least one dose of study treatment. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments | Cetuximab Plus Cisplatin Plus S-1 | 40 | 95% Confidence Interval 24.9 to 56.7 | percentage of participants | |
| Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments | Cetuximab Plus Cisplatin Plus S-1 | 5.6 | 95% Confidence Interval 4.2 to 8.3 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab Plus Cisplatin Plus S-1 | 40 | |
| Overall Study | COMPLETED | Cetuximab Plus Cisplatin Plus S-1 | 32 | |
| Overall Study | NOT COMPLETED | Cetuximab Plus Cisplatin Plus S-1 | 8 |
Source ClinicalTrials.gov
Adverse events98
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 | Leukopenia | Blood and lymphatic system disorders | Cetuximab Plus Cisplatin Plus S-1 | 3 | 40 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cetuximab Plus Cisplatin Plus S-1 | 3 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Cetuximab Plus Cisplatin Plus S-1 | 2 | 40 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cetuximab Plus Cisplatin Plus S-1 | 2 | 40 | |
| other | Trichomegaly | Congenital, familial and genetic disorders | Cetuximab Plus Cisplatin Plus S-1 | 2 | 40 | |
| other | Lacrimation increased | Eye disorders | Cetuximab Plus Cisplatin Plus S-1 | 5 | 40 | |
| other | Stomatitis | Gastrointestinal disorders | Cetuximab Plus Cisplatin Plus S-1 | 26 | 40 | |
| other | Constipation | Gastrointestinal disorders | Cetuximab Plus Cisplatin Plus S-1 | 25 | 40 | |
| other | Diarrhoea | Gastrointestinal disorders | Cetuximab Plus Cisplatin Plus S-1 | 24 | 40 | |
| other | Nausea | Gastrointestinal disorders | Cetuximab Plus Cisplatin Plus S-1 | 20 | 40 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab Plus Cisplatin Plus S-1 | ||
| Total, other adverse events | Cetuximab Plus Cisplatin Plus S-1 | 40 | 40 |
| Total, serious adverse events | Cetuximab Plus Cisplatin Plus S-1 | 15 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33561262 | DERIVED |
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 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/NCT01388790
GET https://conductscience.org/api/trials/v1/NCT01388790/events?page=2