Cetuximab for Elderly Patients With mCRC (NCT01718808) | Clinical Trial Compass
TerminatedPhase 2
Cetuximab for Elderly Patients With mCRC
Stopped: 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.
Switzerland24 participantsStarted 2012-11
Plain-language 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).
Who can participate
Age range70 Years
SexALL
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Inclusion Criteria:
* Patient has given written informed consent before any trial specific treatment
* Histological proven diagnosis of colorectal cancer, metastatic or inoperable advanced, not amenable to curative therapy
* Measurable disease, defined as at least one lesion (outside of irradiated areas) that can be measured in at least one dimension as ≥ 10 mm (≥ 15 mm in case of lymph nodes) according to RECIST v1.1
* Tumour with wild-type KRAS and wild-type BRAF gene
* No previous systemic chemotherapy for metastatic disease (previous adjuvant chemotherapy is allowed if completed \>6 months before randomization, previous rectal radio-chemo therapy if completed \>1 month before randomization)
* WHO performance status 0 or 1
* Age \>75 years; or: age ≥ 70 years with at least one of the following factors:
* Any functional dependence as measured by Instrumental Activities of Daily Life (IADL). Significant comorbidity according to the Cumulative Illness Rating Scale for geriatric patients (CIRS-G; any severe comorbidity \> grade 3 or a total score \> 5 qualifies)
* Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
* Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) (unless known Gilbert-Meulengracht syndrome), aspartate aminotransferase (AST)\<2.5xULN
* Calculated creatinine clearance ≥ 30 ml/min. (according to the formula of Cockcroft-Gault)
* Patient is able to swallow oral medication
* Baseline Quality of Life forms have been completed
Exclusion Criteria:
* Documented or sus…