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
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) or/and
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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival in week 12
A progression event is defined as (whichever occurs first): Progressive disease (PD) assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Death of any cause Starting of second line treatment No tumor assessment 85 days (+/- 7 days) after registration which shows stabilisation or response Patients without tumor assessment at week 12 but with a later assessment showing absence of progression without subsequent treatment will be counted as a progression free at week 12
in week 12
Dirk Kienle, MD