Ignite Creation Date:
2024-05-06 @ 1:01 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01718808
Status:
TERMINATED
Last Update Posted:
2017-01-24
First Post:
2012-10-22
Brief Title:
Cetuximab for Elderly Patients With mCRC
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Cetuximab Monotherapy and Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With KRAS- and BRAF Wild-type Metastatic Colorectal Cancer A Multicenter Phase II Trial
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FU for 3 years from randomization as initially planned is stopped as we do not expect any changes to the endpoints in the future after one year of FU
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVE The objective of the trial is to judge on the benefit obtained by an upfront cetuximab treatment delivered as monotherapy or as part of a combination treatment with capecitabine in vulnerable elderly patients selected for V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog KRAS wild-type and B-type Raf kinase BRAF wild-type metastatic colorectal cancer mCRC
Detailed Description:
Primary endpoint If in a treatment arm the number of patients alive and without progression at 12 weeks is 17 or more this arm will be considered promising otherwise not promising Additionally a two-sided 95 confidence interval for the difference in Progression free survival PFS rates between the two arms will be calculated
Secondary endpoints and patient characteristics
Laboratory values may be expressed as the absolute values continuous variables orand as grading ordinal categorical variables
Generally for each categorical variable the results will be summarized by frequencies and percentages For response rates 95 Clopper-Pearson confidence intervals will be calculated
For each adverse event the results will be summarized by frequencies and percentages of different grades among all cycles as well as by frequencies and percentages of the within-patient worst grades
For each continuous variable the results will be summarized by descriptive statistics
Time-to-event variables will be presented by Kaplan-Meier curves and summarized by medians and 95 confidence intervals
All analysis will be done by treatment arm
Secondary endpoints and patient characteristics
Laboratory values may be expressed as the absolute values continuous variables orand as grading ordinal categorical variables
Generally for each categorical variable the results will be summarized by frequencies and percentages For response rates 95 Clopper-Pearson confidence intervals will be calculated
For each adverse event the results will be summarized by frequencies and percentages of different grades among all cycles as well as by frequencies and percentages of the within-patient worst grades
For each continuous variable the results will be summarized by descriptive statistics
Time-to-event variables will be presented by Kaplan-Meier curves and summarized by medians and 95 confidence intervals
All analysis will be done by treatment arm
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