Trial Information

Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus

OBJECTIVES:

- Compare the pathologic complete response rate in patients with adenocarcinoma of the
esophagus or gastroesophageal junction treated with radiotherapy with pre- and
post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan.

- Compare the survival outcome in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant
chemoradiotherapy in these patients.

- Compare time to progression or recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG
performance status (0 vs. 1) and stage of disease (T2-3, N0, M0 vs. T1-3, N0-1, M0 or M1A).
Patients are randomized to 1 of 2 treatment arms.

- Arm A: Patients receive neoadjuvant radiotherapy once daily, 5 days a week, for 5 weeks
beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV
(Intravenous) over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on
days 1, 8, 22, and 29. Four to six weeks after completion of neoadjuvant
chemoradiotherapy, patients undergo surgical resection. A minimum of 4 weeks after
resection, patients receive adjuvant chemotherapy comprising cisplatin and irinotecan
as above on days 1 and 8. Treatment with adjuvant chemotherapy repeats every 3 weeks
for 3 courses.

- Arm B: Patients receive neoadjuvant radiotherapy as in arm A concurrently with
neoadjuvant chemotherapy comprising paclitaxel IV (Intravenous) over 1 hour followed by
cisplatin IV over 2-3 hours once daily on days 1, 8, 15, 22, and 29. Patients then
undergo surgical resection as in arm A. A minimum of 4 weeks after resection, patients
receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by
cisplatin as above on day 1. Treatment with adjuvant chemotherapy repeats every 3 weeks
for 3 courses.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years,
and then annually for 5 years.

ACCRUAL: A total of 97 patients (50 on Arm A and 47 on Arm B) were accrued for this study.