title: Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508).
abstract: To evaluate the efficacy and the toxicity of prophylactic extended-field carbon-ion radiotherapy (C-ion RT, Protocol 0508) for locally advanced squamous cell carcinoma of the uterine cervix in phase I / II clinical trial. Between May 2006 and January 2012, 26 patients of Protocol 0508 were treated with C-ion RT. The numbers of patients with stage IIB, IIIB, and IVA disease were 13, 11, and 2, respectively. Twenty patients had pelvic lymph node metastases. Median tumor size was 6.1 cm (range, 4.0–10.0 cm). The treatment consisted of extended-field irradiation of 39.0 gray equivalents (GyE) in 13 fractions, and additional 15.0 GyE in 5 fractions was given to the gross tumor volume (GTV) and surrounding tissues. With regard to local boost, 18.0 GyE in 2 fractions was given to GTV only. Total dose to the cervical tumor was 72.0 GyE over 20 fractions. The median follow-up period was 37 months. Twenty-one patients had grade 1 or 2 acute gastrointestinal toxicity, but all patients completed the treatment on schedule. There were no grade 3 or higher late complications, with 8 patients having grade 1 or 2 toxicities, 1 had grade 2 gastrointestinal toxicity and 2 had grade 2 genitourinary toxicity. Four patients (15.4%) developed local recurrence, and 8 patients (30.8%) had distant metastases. The 2-year local control rate, progression-free survival rate and overall survival rate were 83.6%, 61.5% and 73.1%, respectively. There were no severe acute or late complications in this trial. Prophylactic extended-field C-ion RT for locally advanced squamous cell carcinoma of the uterine cervix was a safe treatment. Although the number of patients in this study was small, the results support further investigations to confirm the therapeutic efficacy and to avoid or reduce toxicity.
  
  
  BACKGROUND
  UMIN-CTR UMIN000016169.
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Wakatsuki
authors.affiliation: Department of Radiation Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kato
authors.affiliation: Department of Radiation Oncology, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Kiyohara
authors.affiliation: Gunma University Heavy Ion Medical Center, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ohno
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: Kumiko
authors.initials: K
authors.lastname: Karasawa
authors.affiliation: Department of Radiation Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Tamaki
authors.affiliation: Department of Radiation Oncology, Gunma Prefectural Cancer Center, Ota, Gunma, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Ando
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Tsujii
authors.affiliation: Department of Radiation Oncology, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kamada
authors.affiliation: Department of Reproductive Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.
authors.forename: Makio
authors.initials: M
authors.lastname: Shozu
mesh_terms: D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D004307:Dose-Response Relationship, Radiation; D005260:Female; D063193:Heavy Ion Radiotherapy / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000532:radiotherapy*