EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for Locally Advanced Rectal Cancer (North West Clinical Oncology Group-04 on Behalf of the NCRI Rectal Cancer Subgroup)
- To assess the downstaging effectiveness and tolerability of neoadjuvant
chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and
radiotherapy in patients with locally advanced rectal cancer.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan
hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic
radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6.
Patients undergo surgery 8 weeks after completion of chemoradiotherapy.
After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months.
Peer Reviewed and Funded or Endorsed by Cancer Research United Kindom (UK).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Histologically confirmed R0 resection rate
Week 14 (6 weeks after treatment complete)
Simon Gollins, MD
Glan Clwyd Hospital
United Kingdom: Medicines and Healthcare Products Regulatory Agency