A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus
- To determine whether the addition of cetuximab to definitive chemoradiotherapy
comprising cisplatin, capecitabine, and radiotherapy shows evidence of enhanced overall
survival in patients with carcinoma of the esophagus.
- To determine the safety of this regimen in these patients.
- To determine the feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV over 2 hours on days 1, 22, 43, and 64 and oral
capecitabine twice daily on days 1-84. Beginning in week 7 patients also undergo
radiotherapy 5 days a week for 5 weeks (weeks 7-11). Treatment continues in the absence
of disease progression or unacceptable toxicity.
- Arm II: Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm
I. Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Quality of life and health economics are assessed at baseline, during treatment, and at
pre-specified time points during follow-up.
After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, and then annually for a minimum of 5 years.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-failure rate at 24 weeks
Tom Crosby, MD
Velindre NHS Trust
Medicines and Healthcare Products Regulatory Agency, United Kingdom: