Prospective clinical trial of 12-fraction carbon-ion radiotherapy for primary renal cell carcinoma

Working Group for Genitourinary Tumors

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

The aims of this study were to clarify the safety and efficacy of 12-fraction carbon-ion radiotherapy (CIRT) for primary renal cell carcinoma (RCC) and to confirm the recommended dose in a prospective clinical trial. This clinical trial was planned as a non-randomized, open-label, single-center phase I/II study of CIRT monotherapy. The incidence of acute adverse events was the primary endpoint. Dose-limiting toxicities (DLTs) were defined as grade ≥3 skin, gastrointestinal tract, or urologic adverse events. Based on the eligibility criteria, 8 patients with primary RCC, including 3 medically inoperable patients and 5 patients with tumors >4 cm, were enrolled. of the 8 patients, 5 were treated with 66 Gy (relative biological effectiveness [RBE]), and subsequently, the dose was escalated to 72 Gy (RBE) for the remaining 3 patients. The median follow-up time was 43.1 months. No DLTs were observed at any dose level though the end of follow-up. Although 1 patient died of pneumonia 3 months after CIRT, which was determined to be unrelated to CIRT, no grade 3 or higher adverse events were observed, and both local control and cancer-specific survival rates were 100%. In conclusion, the safety and efficacy of CIRT hypofractionation using 12-fractions for the treatment of eligible RCC patients, including those with inoperable or tumor size >4 cm, were confirmed in this prospective trial, and a recommended dose of 72 Gy (RBE) was established.

Original languageEnglish
Pages (from-to)76-81
Number of pages6
JournalOncotarget
Volume10
Issue number1
Publication statusPublished - 2019 Jan 1

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Heavy Ion Radiotherapy
Renal Cell Carcinoma
Clinical Trials
Relative Biological Effectiveness
Safety
Neoplasms
Gastrointestinal Tract
Pneumonia
Survival Rate
Skin
Incidence

Keywords

  • Carbon-ion radiotherapy
  • Prospective study
  • Radiation therapy
  • Renal cell carcinoma
  • Renal function

ASJC Scopus subject areas

  • Oncology

Cite this

Prospective clinical trial of 12-fraction carbon-ion radiotherapy for primary renal cell carcinoma. / Working Group for Genitourinary Tumors.

In: Oncotarget, Vol. 10, No. 1, 01.01.2019, p. 76-81.

Research output: Contribution to journalArticle

Working Group for Genitourinary Tumors 2019, 'Prospective clinical trial of 12-fraction carbon-ion radiotherapy for primary renal cell carcinoma', Oncotarget, vol. 10, no. 1, pp. 76-81.
Working Group for Genitourinary Tumors. / Prospective clinical trial of 12-fraction carbon-ion radiotherapy for primary renal cell carcinoma. In: Oncotarget. 2019 ; Vol. 10, No. 1. pp. 76-81.
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abstract = "The aims of this study were to clarify the safety and efficacy of 12-fraction carbon-ion radiotherapy (CIRT) for primary renal cell carcinoma (RCC) and to confirm the recommended dose in a prospective clinical trial. This clinical trial was planned as a non-randomized, open-label, single-center phase I/II study of CIRT monotherapy. The incidence of acute adverse events was the primary endpoint. Dose-limiting toxicities (DLTs) were defined as grade ≥3 skin, gastrointestinal tract, or urologic adverse events. Based on the eligibility criteria, 8 patients with primary RCC, including 3 medically inoperable patients and 5 patients with tumors >4 cm, were enrolled. of the 8 patients, 5 were treated with 66 Gy (relative biological effectiveness [RBE]), and subsequently, the dose was escalated to 72 Gy (RBE) for the remaining 3 patients. The median follow-up time was 43.1 months. No DLTs were observed at any dose level though the end of follow-up. Although 1 patient died of pneumonia 3 months after CIRT, which was determined to be unrelated to CIRT, no grade 3 or higher adverse events were observed, and both local control and cancer-specific survival rates were 100{\%}. In conclusion, the safety and efficacy of CIRT hypofractionation using 12-fractions for the treatment of eligible RCC patients, including those with inoperable or tumor size >4 cm, were confirmed in this prospective trial, and a recommended dose of 72 Gy (RBE) was established.",
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