Randomized study of low‐dose versus standard‐dose chemoradiotherapy for unresectable esophageal squamous cell carcinoma (JCOG0303) |
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| Authors: | Masayuki Shinoda Nobutoshi Ando Ken Kato Satoshi Ishikura Hoichi Kato Yasuhiro Tsubosa Keiko Minashi Hiroshi Okabe Yusuke Kimura Tatsuyuki Kawano Shin‐Ichi Kosugi Yasushi Toh Kenichi Nakamura Haruhiko Fukuda Japan Clinical Oncology Group |
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| Affiliation: | 1. Department of Thoracic Surgery, Aichi Cancer Center, Nagoya, Japan;2. Department of Surgery, Tokyo Dental College, Ichikawa General Hospital, Ichikawa, Japan;3. Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan;4. Department of Radiology, Koshigaya Municipal Hospital, Koshigaya, Japan;5. Esophageal Surgical Division, National Cancer Center Hospital, Tokyo, Japan;6. Esophageal Surgical Division, Shizuoka Cancer Center, Shunto‐Gun, Japan;7. Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan;8. Department of Surgery, Kyoto University Hospital, Kyoto, Japan;9. Department of Surgery, Iwate Medical University, Morioka, Japan;10. Department of Esophageal and Gastric Surgery, Tokyo Medical and Dental University, Tokyo, Japan;11. Department of Digestive and General 12. Surgery, Niigata University, Niigata, Japan;13. Department of Gastroenterological 14. Surgery, National Kyushu Cancer Center, Fukuoka, Japan;15. JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan |
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| Abstract: | Low‐dose cisplatin and 5‐fluorouracil (LDPF) chemotherapy with daily radiotherapy (RT) is used as an alternative chemoradiotherapy regimen for locally advanced esophageal carcinoma. We evaluated whether RT plus LDPF chemotherapy had an advantage in terms of survival and/or toxicity over RT plus standard‐dose cisplatin and 5‐fluorouracil (SDPF) chemotherapy in this study. This multicenter trial included esophageal cancer patients with clinical T4 disease and/or unresectable regional lymph node metastasis. Patients were randomly assigned to receive RT (2 Gy/fraction, total dose of 60 Gy) with SDPF (arm A) or LDPF (arm B) chemotherapy. The primary endpoint was overall survival (OS). A total of 142 patients (arm A/B, 71/71) from 41 institutions were enrolled between April 2004 and September 2009. The OS hazard ratio in arm B versus arm A was 1.05 (80% confidence interval, 0.78–1.41). There were no differences in toxicities in either arm. Arm B was judged as not promising for further evaluation in the phase III setting. Thus, the Data and Safety Monitoring Committee recommended that the study be terminated. In the updated analyses, median OS and 3‐year OS were 13.1 months and 25.9%, respectively, for arm A and 14.4 months and 25.7%, respectively, for arm B. Daily RT plus LDPF chemotherapy did not qualify for further evaluation as a new treatment option for patients with locally advanced unresectable esophageal cancer. This study was registered at the UMIN Clinical Trials Registry as UMIN000000861. |
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| Keywords: | Chemoradiotherapy esophageal squamous cell carcinoma randomized trial survival toxicity |
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