Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154102
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2005-09-08
Brief Title:
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer CRYSTAL
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
Open Randomized Controlled Multicenter Phase III Study Comparing 5FU FA Plus Irinotecan Plus Cetuximab Versus 5FUFA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYSTAL
Brief Summary:
Drugs used against cancer work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as cetuximab can block tumor growth in different ways Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer 1st-line treatment may improve the treatment efficacy However it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy 5-Fluorouracil 5FUFolinic acid FA plus irinotecan for metastatic colorectal cancer in first-line setting compared to the same chemotherapy alone on patient expressing the epidermal growth factor EGF receptor
Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab open-label study and will then be treated until progression of the disease or unacceptable toxicity occur Regular efficacy assessments every 8 weeks based on imaging will be performed throughout the study together with regular safety assessments eg safety labs An independent Safety Board of experts will also monitor safety data
After participant discontinuation from the trial regular updates on further treatments and survival status will be requested from the investigator
The entire study from the first patient entering the study to the last collect of follow-up information is 4-5 years long
Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab open-label study and will then be treated until progression of the disease or unacceptable toxicity occur Regular efficacy assessments every 8 weeks based on imaging will be performed throughout the study together with regular safety assessments eg safety labs An independent Safety Board of experts will also monitor safety data
After participant discontinuation from the trial regular updates on further treatments and survival status will be requested from the investigator
The entire study from the first patient entering the study to the last collect of follow-up information is 4-5 years long
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None