Trial Information

A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus

OBJECTIVES:

- Compare survival and quality of life of patients with resectable adenocarcinoma of the
esophagus treated prior to surgery with standard chemotherapy comprising cisplatin and
fluorouracil versus prolonged infusional chemotherapy comprising cisplatin, epirubicin,
and fluorouracil.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms.

- Arm I (Standard chemotherapy): Patients receive cisplatin IV over 4 hours on days 1-4
and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2
courses in the absence of disease progression or unacceptable toxicity.

- Arm II (Infusional chemotherapy): Patients receive cisplatin IV over 4 hours on day 1,
epirubicin IV on day 1, and fluorouracil IV continuously. Treatment repeats every 21
days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery 4-6 weeks after the last dose of fluorouracil in arm I or anytime
after the fluorouracil infusion is completed in arm II.

Quality of life is assessed at baseline, immediately before starting the last course of
chemotherapy, immediately before surgery, 6 weeks post-operatively, and at 6, 9, 12, 18, and
24 months after randomization.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then
annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 1,300 patients (650 per treatment arm) will be accrued for
this study.