Trial · NCT00154102
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
NCT00154102, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2011-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL). Trials, record NCT00154102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00154102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
- NCT number
- NCT00154102
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,221 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
- Interventions
- Cetuximab, FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
- First posted
- 2005-09-12
- Last updated
- 2017-01-30
- Results first posted
- 2011-02-23
- Limitations and caveats
- A non-specific outcome measure 'Safety' was deleted from the entry in error. A replacement outcome was created. The outcome refers to adverse events.
Source ClinicalTrials.gov
Registered outcomes15
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 randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. |
| Primary | Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments | Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. |
| Primary | Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments | Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. |
| Secondary | Overall Survival Time (OS) | Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009 | Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later. |
| Secondary | Overall Survival Time (KRAS Wild-Type Population) | Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009 | Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later. |
| Secondary | Overall Survival Time (KRAS Mutant Population) | Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009 | Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later. |
| Secondary | Best Overall Response Rate - Independent Review Committee (IRC) Assessments | evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). |
| Secondary | Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments | evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). |
| Secondary | Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments | evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). |
| Secondary | Disease Control Rate - Independent Review Committee (IRC) Assessments | Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized). | months | MEDIAN |
| PRIMARY | Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments | Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009 | months | MEDIAN |
| PRIMARY | Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments | Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009 | months | MEDIAN |
| SECONDARY | Overall Survival Time (OS) | Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009 | ITT population (allocation to treatment groups as randomized and treated) | months | MEDIAN |
| SECONDARY | Overall Survival Time (KRAS Wild-Type Population) | Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009 | Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009 | months | MEDIAN |
| SECONDARY | Overall Survival Time (KRAS Mutant Population) | Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009 | Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009 | months | MEDIAN |
| SECONDARY | Best Overall Response Rate - Independent Review Committee (IRC) Assessments | evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | ITT population (allocation to treatment groups as randomized and treated) | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments | evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009 | percentage participants | NUMBER |
| SECONDARY | Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments | evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009 | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate - Independent Review Committee (IRC) Assessments | Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006 | ITT population (allocation to treatment groups as randomized and treated) | percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group50
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 FOLFIRI | 8.9 | 95% Confidence Interval 8.0 to 9.4 | months | |
| Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments | FOLFIRI Alone | 8.0 | 95% Confidence Interval 7.6 to 9.0 | months | |
| Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments | Cetuximab Plus FOLFIRI | 9.9 | 95% Confidence Interval 9.0 to 11.3 | months | |
| Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments | FOLFIRI Alone | 8.4 | 95% Confidence Interval 7.4 to 9.2 | months | |
| Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments | Cetuximab Plus FOLFIRI | 7.4 | 95% Confidence Interval 6.1 to 8.0 | months | |
| Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments | FOLFIRI Alone | 7.7 | 95% Confidence Interval 7.3 to 9.2 | months | |
| Overall Survival Time (OS) | Cetuximab Plus FOLFIRI | 19.9 | 95% Confidence Interval 18.5 to 21.3 | months | |
| Overall Survival Time (OS) | FOLFIRI Alone | 18.6 | 95% Confidence Interval 16.7 to 19.8 | months | |
| Overall Survival Time (KRAS Wild-Type Population) | Cetuximab Plus FOLFIRI | 23.5 | 95% Confidence Interval 21.2 to 26.3 | months | |
| Overall Survival Time (KRAS Wild-Type Population) | FOLFIRI Alone | 20.0 | 95% Confidence Interval 17.4 to 21.7 | months |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 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 FOLFIRI | 599 | |
| Overall Study | STARTED | FOLFIRI Alone | 599 | |
| Overall Study | COMPLETED | Cetuximab Plus FOLFIRI | 592 | |
| Overall Study | COMPLETED | FOLFIRI Alone | 597 | |
| Overall Study | NOT COMPLETED | Cetuximab Plus FOLFIRI | 7 | |
| Overall Study | NOT COMPLETED | FOLFIRI Alone | 2 |
Source ClinicalTrials.gov
Adverse events650
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 FOLFIRI | 272 | 600 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | FOLFIRI Alone | 249 | 602 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Cetuximab Plus FOLFIRI | 127 | 600 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | FOLFIRI Alone | 120 | 602 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Cetuximab Plus FOLFIRI | 121 | 600 | |
| other | ANAEMIA | Blood and lymphatic system disorders | FOLFIRI Alone | 127 | 602 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Cetuximab Plus FOLFIRI | 31 | 600 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | FOLFIRI Alone | 20 | 602 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Cetuximab Plus FOLFIRI | 29 | 600 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | FOLFIRI Alone | 35 | 602 |
1 to 10 of 650Source ClinicalTrials.gov
See all 650 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab Plus FOLFIRI | ||
| Total, all-cause mortality | FOLFIRI Alone | ||
| Total, other adverse events | Cetuximab Plus FOLFIRI | 593 | 600 |
| Total, other adverse events | FOLFIRI Alone | 591 | 602 |
| Total, serious adverse events | Cetuximab Plus FOLFIRI | 263 | 600 |
| Total, serious adverse events | FOLFIRI Alone | 204 | 602 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cetuximab Plus FOLFIRI vs FOLFIRI Alone: Safety - Number of Patients Experiencing Any Adverse Event | Trial comparisons |
| Cetuximab Plus FOLFIRI vs FOLFIRI Alone: Participants With No Residual Tumor After Metastatic Surgery | Trial comparisons |
| Cetuximab Plus FOLFIRI vs FOLFIRI Alone: 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/NCT00154102
GET https://conductscience.org/api/trials/v1/NCT00154102/results?page=2