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Japanese Journal of Clinical Oncology Advance Access originally published online on June 23, 2009
Japanese Journal of Clinical Oncology 2009 39(10):638-643; doi:10.1093/jjco/hyp069
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© The Author (2009). Published by Oxford University Press. All rights reserved

A Phase II Trial of Chemoradiotherapy for Stage I Esophageal Squamous Cell Carcinoma: Japan Clinical Oncology Group Study (JCOG9708)

Hoichi Kato1, Akihiro Sato2, Haruhiko Fukuda1, Yoshikazu Kagami1, Harushi Udagawa3, Akihiko Togo4, Nobutoshi Ando5, Otsuo Tanaka6, Masayuki Shinoda7, Hideaki Yamana8 and Satoshi Ishikura1

1 National Cancer Center, Tokyo
2 National Cancer Center East, Chiba
3 Toranomon General Hospital
4 Togo Clinic
5 Tokyo Dental College, Tokyo
6 Niigata Cancer Center, Niigata
7 Aichi Cancer Center, Aichi
8 Kurume University Hospital, Fukuoka, Japan

For reprints and all correspondence: Akihiro Sato, Research Center for Innovative Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: asato{at}east.ncc.go.jp

Received February 5, 2009; accepted May 26, 2009

Objective: The study objective was to evaluate the efficacy and toxicity of chemoradiotherapy with 5-fluorouracil (5-FU) plus cisplatin in patients with Stage I esophageal squamous cell carcinoma (ESCC). The primary endpoint was proportion of complete response (%CR).

Methods: Patients with Stage I (T1N0M0) ESCC, aged 20–75 years, without indication of endoscopic mucosal resection were eligible. Treatment consisted of cisplatin 70 mg/m2 (day 1) and 5-FU 700 mg/m2/day (days 1–4) combined with 30 Gy radiotherapy (2 Gy/day, 5 days/week, days 1–21). The cycle was repeated twice with 1-week split. Salvage surgery was recommended for residual tumor or local recurrence.

Results: From December 1997 to June 2000, 72 patients were enrolled. No ineligible patient or major protocol violation was observed. There were 63 CRs for %CR of 87.5% [95% confidence interval (CI): 77.6–94.1]. Six patients with residual tumor successfully underwent esophagectomy. There was no Grade 4 toxicity. Four-year survival proportion was 80.5% (95% CI: 71.3–89.7), and 4-year major relapse-free survival proportion was 68% (95% CI: 57.3–78.8) (mucosal recurrence removed by endoscopy was not counted as an event).

Conclusions: High CR proportion and survival proportion with mild toxicity suggest that this regimen could be considered as a candidate of new standard treatment to be compared with surgery in patients with Stage I ESCC.

Key Words: esophageal neoplasms • combined modality therapy • clinical trial • Phase II • radiotherapy


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