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S-1 versus S-1 plus cisplatin concurrent intensity modulated radiation therapy in the treatment of esophageal
Yixue Wen1, Zhenhuan Zhao, Jidong Miao
1Department of Oncology, Mianyang Central Hospital, Mian Yang Department of Oncology, Affiliated Hospital of North Sichuan Medical College, Nan Chong Department of Oncology, Zigong Fourth People's Hospital, Zi Gong Department of Oncology, Ziyang People's Hospital, Zi Yang Department of Oncology, Guangyuan First People's Hospital, Guang Yuan Department of Oncology, Jiangyou People's Hospital Department of Oncology, Jiangyou Second People's Hospital, Jiang You Department of Oncology, Jianyang People's Hospital, Jian Yang, Sichuan, People's Republic of China.
Introduction:
Chemotherapy regimens are often a 2-drug regimen in concurrent chemotherapy and radiotherapy for esophageal cancer (EC). However, some retrospective studies have suggested that for patients with EC receiving radiotherapy combined with 2-drug chemotherapy have the severe toxicity. And S-1 alone with the combination of radiotherapy treatment effect is good, and achieved good clinical remission rate. The purpose of this trial is compare the efficacy and toxicity of combining S-1 or S-1 plus cisplatin with radiotherapy for esophageal squamous cell carcinoma.
Methods/Design:
The study is a randomized, controlled, multicenter trial, comparing S-1 versus S-1 plus cisplatin concurrent radiotherapy for patients with esophageal squamous cell carcinoma. Eighty-eight patients with unresectable or medically unfit for surgery esophageal squamous cell carcinoma (clinical stage I to III), will randomly assigned to receive four cycles (2 concomitant and 2 postradiotherapy) S-1 or S-1 plus cisplatin along with radiotherapy 60-66 Gy/30 to 33 fractions. The primary outcome is complete response rate of primary tumor which will be measured by endoscopy and computer screen at 3 months after the completion of treatment. Secondary outcomes include survival and toxicity.
Discussion:
To our knowledge, this study protocol is the first to test the effect between S-1 versus S-1 plus cisplatin concurrent intensity modulated radiation therapy in the treatment of esophageal squamous cell carcinoma. If the result will be the same effect and fewer side effects and less costly in S-1 plus radiotherapy. It will supply more treatment selection for esophageal squamous cell carcinoma.
