| Trial name or title |
Colorectal Cancer (CRC) Cetuximab Elderly Frail |
| Methods |
Open‐label randomised controlled trial |
| Participants |
People with KRAS exon 2 WT mCRC, age >= 80 or >= 70 in combination with functional restrictions defined as limitation in at least 2 of 8 instrumental activities of daily living (IADL) |
| Interventions |
5‐FU with cetuximab (interventional arm), 5‐FU alone (control arm) |
| Outcomes |
Primary outcome: PFS. Secondary outcomes: OS, response rate, change in IADL score, change in G8 geriatric assessment screening tool, change in social situation, quality of life (EORTC QLQ‐C30 and QLQ‐ELD14), occurrence of adverse events, health economy assessments, score of Elderly Minimal Dataset Comprehensive Geriatric Assessment (EMDCGA) as evaluated by G8 instrument, score of EMDCGA as evaluated by IADL questionnaire, score of EMDCGA as evaluated by social situation questionnaire |
| Starting date |
April 2013 |
| Contact information |
EORTC; study chairs Marc Peeters (Belgium) and Ulrich Wedding (Germany) |
| Notes |
Study terminated due to poor accrual; awaiting publication of data. |
