title: A phase I/II clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.
abstract: This paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients.
  
  
  
  Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT.
  
  
  
  The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique.
  
  
  
  UMIN000019081 ; Registration date: 2015/9/30.
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. namuraka@ncc.go.jp.
authors.forename: Naoya
authors.initials: N
authors.lastname: Murakami
authors.affiliation: Department of Radiation Oncology, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-shi, Saitama, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kato
authors.affiliation: Department of Radiation Oncology, Gunma University Graduate School of Medicine, 3-39-45 Showamachi, Maebashi, Gunma, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
authors.affiliation: Diagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Uno
authors.affiliation: Department of Biostatistics, Yokohama City University, 22-2 Seto, Kanazawa-ku, Yokohama, 236-0027, Japan.
authors.forename: Takeharu
authors.initials: T
authors.lastname: Yamanaka
authors.affiliation: Department of Radiation Oncology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Sakurai
authors.affiliation: Department of Radiation Therapeutics and Oncology, Tokyo Medical and Dental University, 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo, 113-8519, Japan.
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Yoshimura
authors.affiliation: Department of Radiation Oncology, Kawasaki Medical School, Matsushima 577, Kurashiki, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Hiratsuka
authors.affiliation: Department of Radiation Oncology, Yamagata University Faculty of Medicine, Yamagata, 990-9585, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Kuroda
authors.affiliation: Department of Radiology, Kagawa Prefectural Central Hospital, 1-2-1 Asahi-cho, Takamatsu-shi, Kagawa, Japan.
authors.forename: Kotaro
authors.initials: K
authors.lastname: Yoshio
authors.affiliation: Department of Radiation Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Itami
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001918:Brachytherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage* / Q000627:therapeutic use; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011878:Radiotherapy; D011879:Radiotherapy Dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000628:therapy*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin
keywords: A prospective clinical trial protocol; Hybrid of intracavitary and interstitial brachytherapy; Uterine cervical cancer