A Randomised Phase II Study of Radio-chemotherapy With or Without Panitumumab (Vectibix®) in Irresectable Squamous Cell Carcinoma or Adenocarcinoma of the Oesophagus
A complete response rate of approximately 30% is achieved for standard treatment of
irresectable carcinoma of the oesophagus, consisting of concurrent chemoradiation therapy
(50.5 Gy + cisplatin/5-FU). Attempts to improve outcome by intensifying conventional
cytotoxic drugs or increasing the radiation dose have not been successful. Future
improvements will likely require the incorporation of targeted agents that probably will not
add significant toxicity, the use of molecular predictors of response and early
identification of responders. In both squamous cell carcinoma and adenocarcinoma of the
oesophagus expression of EGFR is correlated with poor outcome. Furthermore the addition of
cetuximab, a chimaeric EGFR antibody, to radiation therapy in head and neck cancer and
non-small cell lung cancer showed a gain in overall survival. In head and neck cancer
studies with the addition of panitumumab to chemo-radiation therapy are currently ongoing.
Therefore, we propose to perform a randomised phase II study of chemo-radiation therapy with
or without the combination of panitumumab (human EGFR antibody) in irresectable squamous
cell carcinoma or adenocarcinoma of the oesophagus without distant metastases.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
1-year overall survival
To describe the 1-year OS rate after concurrent CRT with or without panitumumab in irresectable carcinoma of the oesophagus. The control arm is used to validate whether the historical cohort used for comparison is similar to our success-rate.
C.M.L. van Herpen, Md PhD
University Medical Centre Nijmegen
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)