Phase I trial of escalating-dose cisplatin with 5-fluorouracil and concurrent radiotherapy in Chinese patients with esophageal cancer

Qiang Lin, Xian Shu Gao, Xue Ying Qiao, Zhi Guo Zhou, Ping Zhang, Kun Chen, Yan Nan Zhao, Junichi Asaumi

Research output: Contribution to journalArticle

15 Citations (Scopus)


We defined the maximum-tolerated dose (MTD) of chemoradiotherapy (cisplatin (CDDP) with 5-fluorouracil (5-FU) and concurrent chemoradiotherapy) for Chinese patients with esophageal cancer. Twenty-one previously untreated patients with primary esophageal cancer were entered into this study. Escalating doses of CDDP with 5-FU were administered in a modified Fibonacci sequence, with concurrent conventional fractionation radiotherapy (CFR) of 60 Gy or 50 Gy. The starting doses were CDDP 37.5 mg/m2 on day 1, and 5-FU 500 mg/m2 on days 1-5, respectively. The regimen was repeated 4 times every 28 days. If no dose-limiting toxicity (DLT) was observed, the next dose level was applied. The procedures were repeated until DLT appeared. The MTD was declared to be 1 dose level below the level at which DLT appeared. DLT was grade 3 radiation-induced esophagitis at a dose level of CDDP 60 mg/m2 with 5-FU 700 mg/m 2 and concurrent 60 Gy CFR. MTD was defined as CDDP 52.5 mg/m 2 with 5-FU 700 mg/m2 and concurrent 50 Gy CFR. The MTD of CDDP with 5-FU and in concurrent chemoradiotherapy for Chinese patients with esophageal cancer is CDDP 52.5 mg/m2 on day 1 and 5FU 700 mg/m 2 on days 1-5, repeated 4 times every 28 days, and concurrent 50 Gy CFR. Further evaluation of this regimen in a prospective phase II trial is ongoing. Copyright

Original languageEnglish
Pages (from-to)37-44
Number of pages8
JournalActa medica Okayama
Issue number1
Publication statusPublished - Feb 1 2008



  • 5-fluorouracil
  • Cisplatin
  • Concurrent chemoradiotherapy
  • Dose escalation
  • Esophageal neoplasm

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this