drugset / Trial / NCT01718808
Cetuximab for Elderly Patients With mCRC
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2012-11
- Primary completion
- 2015-12
- Completion
- 2017-01
Outcome
Outcome not reported
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.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 750 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Cetuximab | Monoclonal antibody | 500 mg/m2 | — |