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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01718808
Other study ID # SAKK 41/10
Secondary ID
Status Terminated
Phase Phase 2
First received October 22, 2012
Last updated January 23, 2017
Start date November 2012
Est. completion date January 2017

Study information

Verified date January 2017
Source Swiss Group for Clinical Cancer Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cetuximab
Cetuximab 500 mg/m2 every second week (days 1, 15, 29, etc.) until progression or unacceptable toxicity
Capecitabine
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

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Sponsors (1)

Lead Sponsor Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Quality of life (QL) Baseline, in week 7, 13 and 19
Secondary Adverse events (CTCAE v 4.0) 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).
Secondary Overall Response (OR) Before start of treatment. In week 13 and every 12 weeks up to 2 years.
Secondary Progression free survival (PFS) PFS will be calculated sustained from randomization until documented PD or death, whichever occurs first (estimated up to 2 years).
Secondary Overall Survival (OS) Overall survival will be calculated from randomization until death (estimated up to 2 years).
Secondary Overall treatment utility (OTU) (predefined composite endpoint including clinical benefit, tolerability and acceptability of the treatment) Until week 19.
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