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A multi-institutional dose-finding and efficacy confirmation trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC): Results of dose-finding phase

Date

09 Oct 2016

Session

Poster display

Presenters

Tomohiro Sakashita

Citation

Annals of Oncology (2016) 27 (6): 328-350. 10.1093/annonc/mdw376

Authors

T. Sakashita1, A. Homma1, R. Onimaru2, K. Matsuura3, H. Shinomiya4, R. Hayashi5, K. Shiga6, H. Tachibana7, K. Nakamura8, J. Mizusawa9, M. Fujii10

Author affiliations

  • 1 Otolaryngology-head And Neck Surgery, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 2 Radiology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 3 Head And Neck Surgery, Miyagi Cancer Center, Natori/JP
  • 4 Otolaryngology-head And Neck Surgery, Kobe University Graduate School of Medicine, Kobe/JP
  • 5 Head And Neck Surgery Division, National Cancer Center Hospital East, Kashiwa/JP
  • 6 Otolaryngology - Head And Neck Surgery, Iwate Medical University School of Medicine, Morioka/JP
  • 7 Radiation Oncology, Aichi Cancer Center Hospital, Nagoya/JP
  • 8 Japan Clinical Oncology Group Operations Office, National Cancer Center Hospital, Tokyo/JP
  • 9 Jcog Data Center/operations Office, Center For Research Administration And Support, National Cancer Center Hospital, Tokyo/JP
  • 10 Otorhinolaryngology, National Tokyo Medical Center, Tokyo/JP
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Resources

Abstract 982

Background

Superselective intra-arterial infusion of high-dose cisplatin with concomitant radiotherapy (RADPLAT) has been performed for the patients with locally advanced maxillary sinus squamous cell carcinomas (LA-MSSCCs) in several institutions and has been reported to result in a favorable survival. This multi-institutional prospective trial was aimed to confirm the adequate dose and efficacy of RADPLAT for the patients with LA-MSSCCs. The dose-finding phase was performed to evaluate the incidence of dose-limiting toxicity (DLT) and to determine the recommended cycle of intra-arterial infusion of cisplatin.

Methods

Eighteen patients were registered from 7 institutions for this study. In this dose-finding study, 100 mg/m2 of cisplatin was administered intra-arterially weekly for 7 weeks with concomitant radiotherapy (total 70 Gy). Cisplatin was skipped in the case of adverse events that met the skipping rule defined by the protocol. The recommended number of cycles was determined according to the distribution of the number of cycles of administered cisplatin and the incidence of DLT.

Results

The median age of all participants was 64 years old (range, 40-75 years old). Sixteen patients were diagnosed as T4aN0M0, and two patients as T4bN0M0. All patients achieved full dose of radiotherapy. The number of cycles of administered cisplatin was 7 in 13 patients and 6 in 5. DLT was observed in 5 patients; Gr 3 liver dysfunction (1), Gr 4 thrombocytopenia (1), Ccr 

Conclusions

RADPLAT appears to be safe and well-tolerated at 7 cycles of cisplatin at a dose of 100 mg/m2 each cycle, which were determined to be the recommended number of cycles for LA-MSSCC.

Clinical trial identification

UMIN000013706.

Legal entity responsible for the study

N/A

Funding

Research Funding Source Name: the Practical Research for Innovative Cancer Control(15ck0106137h0002)

Disclosure

All authors have declared no conflicts of interest.

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