title: Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701.
abstract: OBJECTIVE
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, 216-8511, Japan. mimura@marianna-u.ac.jp.|Department of Radiology, Okayama University Medical School, 2-5-1 Shikata, Kita-ku, Okayama, 700-8558, Japan. mimura@marianna-u.ac.jp.
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Mimura
authors.affiliation: Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Arai
authors.affiliation: Department of Interventional Radiology, Mie University School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Yamakado
authors.affiliation: Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.|Department of Radiology, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505, Japan.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Sone
authors.affiliation: Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Takeuchi
authors.affiliation: Department of Urology, Kyoto Prefectural University of Medicine, 465 Kajiichi, Hirokoji agaru, Kawaramachi-douri, Kamijo-ku, Kyoto, 602-8566, Japan.
authors.forename: Tsuneharu
authors.initials: T
authors.lastname: Miki
authors.affiliation: Department of Radiology, Okayama University Medical School, 2-5-1 Shikata, Kita-ku, Okayama, 700-8558, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Gobara
authors.affiliation: Department of Diagnostic and Interventional Radiology, Hokkaido University School of Medicine, 7 Nishi, 15-jo Kita, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Sakuhara
authors.affiliation: Department of Radiology, Tochigi Cancer Center, 4-9-13 Yonan, Utsunomiya, Tochigi, 320-0834, Japan.
authors.forename: Takanobu
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, 1-1 Kanokogoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
authors.forename: Yozo
authors.initials: Y
authors.lastname: Sato
authors.affiliation: Department of Radiology, Okayama University Medical School, 2-5-1 Shikata, Kita-ku, Okayama, 700-8558, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Kanazawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002292:Carcinoma, Renal Cell / Q000601:surgery*; D017115:Catheter Ablation / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007564:Japan; D007680:Kidney Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D015642:Radiology, Interventional; D016896:Treatment Outcome; D055815:Young Adult
keywords: Ablation; Cancer; Clinical practice; Interventional oncology; Kidney/renal; Nonvascular interventions; Radiofrequency ablation; Tumor/tumour/neoplasm