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).
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 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Cetuximab 500 mg/m2 every second week (days 1, 15, 29, etc.) until progression or unacceptable toxicity
Capecitabine 1000 mg/m2 bid p.o. (750 mg/m2 if creatinine clearance 30-50 ml/min according to Cockroft-Gault formula, on days 1-14 every 3 weeks, restart on day 22
Universitaetsspital-Basel
Basel, Switzerland
Inselspital, Bern
Bern, Switzerland
Spitalzentrum Biel
Biel, Switzerland
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
Time frame: in week 12
Quality of life (QL)
Time frame: Baseline, in week 7, 13 and 19
Adverse events (CTCAE v 4.0)
Time frame: Adverse events are assessed by Common terminology criteria for adverse events (CTCAE) v4.0. From randomization until 30 days after end of treatment (estimated up to 2 years).
Overall Response (OR)
Time frame: Before start of treatment. In week 13 and every 12 weeks up to 2 years.
Progression free survival (PFS)
Time frame: PFS will be calculated sustained from randomization until documented PD or death, whichever occurs first (estimated up to 2 years).
Overall Survival (OS)
Time frame: Overall survival will be calculated from randomization until death (estimated up to 2 years).
Overall treatment utility (OTU) (predefined composite endpoint including clinical benefit, tolerability and acceptability of the treatment)
Time frame: Until week 19.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hopital Fribourgeois
Fribourg, Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
Kantonsspital Muensterlingen
Muensterlingen, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland
SpitalSTS AG Simmental-Thun-Saanenland
Thun, Switzerland
...and 4 more locations