Trial Information

Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer

OBJECTIVES:

- Compare the survival of patients with locally advanced esophageal cancer treated with
neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin
followed by surgery or radiotherapy and chemotherapy.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
gender, histology (epidermoid vs glandular), response to induction therapy (complete vs
partial), and tumor differentiation (little differentiated vs undifferentiated/good vs
moderately differentiated).

- Induction therapy: All patients receive induction therapy comprising fluorouracil IV
continuously over 24 hours on days 1-5 and cisplatin IV over 1 hour on days 1-5 or on
day 2. Treatment repeats every 21 days for 2 courses in the absence of disease
progression or unacceptable toxicity. Patients also undergo radiotherapy twice daily on
days 1-5 and 22-26 or once daily 5 days a week for 4½ weeks. Patients achieving
complete or partial response are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo surgery. Patients may receive 1 course of adjuvant chemotherapy
(as in induction therapy) and undergo additional radiotherapy.

- Arm II: Patients receive additional fluoroucacil and cisplatin as in induction therapy.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity. Patients also undergo additional radiotherapy once daily 5 days
a week for 2 weeks.

Quality of life is assessed at baseline, after treatment on arms I or II, and then every 2
months (arm I) or every 6 months (arm II) thereafter.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.