Irresectable Squamous Cell or Adenocarcinoma of the Oesophagus Clinical Trial
Official title:
A Randomised Phase II Study of Radio-chemotherapy With or Without Panitumumab (Vectibix®) in Irresectable Squamous Cell Carcinoma or Adenocarcinoma of the Oesophagus
For esophageal cancer that can not be removed by surgery, the choice of treatment is a
combination of chemotherapy and radiotherapy. We call this combination- (or concurrent)
chemoradiotherapy. Chemotherapy is treatment with drugs that kill cancer cells. Both
chemotherapy and radiotherapy make the tumour smaller and enhance each other's effect. The
goal of treatment with chemotherapy and radiation therapy is to cure the cancer.
Unfortunately only a small proportion of patients are cured with this treatment.
Improvements in the outcome of treatment may be expected by using the so-called "targeted"
treatments. With esophageal cancer, a protein (the epidermal growth factor receptor (this is
a kind of trap), the EGFR), is present in many tumours. This protein causes the tumor to
grow. Panitumumab is a drug that blocks the functioning of this receptor (catcher), so that
possibly the growth and spread of esophageal cancer is prevented.
The main objective of this trial is to see if survival of patients with inoperable
esophageal cancer improves as panitumumab is added to standard treatment with
chemoradiotherapy.
It will also investigate whether patients tolerate the addition of panitumumab to the
standard treatment. Also, the biological characteristics of the tumor will be examined. In a
proportion of patients it will be determined how the enhancement of the cancer is visible on
an FDG-PET scan before the start of treatment and how this changes during the treatment. It
will be also be evaluated how this treatment affects the survival.
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