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Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

  • Hidefumi MimuraEmail author
  • Yasuaki Arai
  • Koichiro Yamakado
  • Miyuki Sone
  • Yoshito Takeuchi
  • Tsuneharu Miki
  • Hideo Gobara
  • Yusuke Sakuhara
  • Takanobu Yamamoto
  • Yozo Sato
  • Susumu Kanazawa
Clinical Investigation

Abstract

Purpose

This multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.

Methods

Thirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.

Results

The RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).

Conclusion

The current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

Keywords

Interventional oncology Nonvascular interventions Ablation Radiofrequency ablation Kidney/renal Cancer Tumor/tumour/neoplasm Clinical practice 

Notes

Acknowledgments

This work was supported by the Health and Labour Sciences Research Grants from the Japanese Ministry of Health, Labour and Welfare.

Compliance with Ethical Standards

Conflict of interest

HM, KY, TM, HG, and TY reported grants from the Japanese Ministry of Health, Labour and Welfare as mentioned above during the conduct of the study. All remaining authors have declared no conflicts of interest.

Statement of Informed Consent

Informed consent was obtained from all individual participants included in the study.

Statement of Human and Animal Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Supplementary material

270_2015_1275_MOESM1_ESM.docx (14 kb)
Supplementary material 1 (DOCX 13 kb)

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Copyright information

© Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2015

Authors and Affiliations

  • Hidefumi Mimura
    • 1
    • 2
    Email author
  • Yasuaki Arai
    • 3
  • Koichiro Yamakado
    • 4
  • Miyuki Sone
    • 3
    • 5
  • Yoshito Takeuchi
    • 3
  • Tsuneharu Miki
    • 6
  • Hideo Gobara
    • 2
  • Yusuke Sakuhara
    • 7
  • Takanobu Yamamoto
    • 8
  • Yozo Sato
    • 9
  • Susumu Kanazawa
    • 2
  1. 1.Department of RadiologySt. Marianna University School of MedicineKawasakiJapan
  2. 2.Department of RadiologyOkayama University Medical SchoolOkayamaJapan
  3. 3.Department of Diagnostic RadiologyNational Cancer Center HospitalTokyoJapan
  4. 4.Department of Interventional RadiologyMie University School of MedicineTsuJapan
  5. 5.Department of RadiologyIwate Medical UniversityMoriokaJapan
  6. 6.Department of UrologyKyoto Prefectural University of MedicineKyotoJapan
  7. 7.Department of Diagnostic and Interventional RadiologyHokkaido University School of MedicineSapporoJapan
  8. 8.Department of RadiologyTochigi Cancer CenterUtsunomiyaJapan
  9. 9.Department of Diagnostic and Interventional RadiologyAichi Cancer Center HospitalNagoyaJapan

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