Dose-finding and efficacy confirmation trial of the superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for locally advanced maxillary sinus cancer (Japan Clinical Oncology Group 1212): Dose-finding phase

Head Neck. 2018 Mar;40(3):475-484. doi: 10.1002/hed.25001. Epub 2017 Nov 11.


Background: We are currently undertaking a multi-institutional prospective trial of the superselective intra-arterial infusion of high-dose cisplatin with concomitant radiotherapy for patients with T4aN0M0 or T4bN0M0 locally advanced maxillary sinus squamous cell carcinomas (SCC). We herein report the results of the dose-finding phase.

Methods: The dose-finding phase sought to evaluate the incidence of dose-limiting toxicities and determine the recommended number of cycles of the intra-arterial infusion of cisplatin. In this phase, 100 mg/m2 of cisplatin was administered intra-arterially weekly for 7 weeks with concomitant radiotherapy (70 Gy).

Results: All 18 patients received a full dose of radiotherapy. The number of cycles of cisplatin was 7 in 13 patients and 6 in 5 patients. The dose-limiting toxicities were observed in 5 patients.

Conclusion: These results indicated that this therapy is safe and well-tolerated at 7 cycles of cisplatin, which was determined to be the recommended number of cycles for locally advanced maxillary sinus SCC.

Keywords: chemoradiotherapy; cisplatin; intra-arterial; maxillary sinus cancer; squamous cell carcinoma.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Chemoradiotherapy / methods*
  • Cisplatin / administration & dosage*
  • Cisplatin / adverse effects
  • Female
  • Follow-Up Studies
  • Humans
  • Infusions, Intra-Arterial
  • Japan
  • Male
  • Maxillary Sinus / pathology
  • Maxillary Sinus Neoplasms / therapy*
  • Middle Aged
  • Prospective Studies
  • Treatment Outcome
  • Young Adult


  • Antineoplastic Agents
  • Cisplatin