title: Dose-escalation study of carbon ion radiotherapy for locally advanced squamous cell carcinoma of the uterine cervix (9902).
abstract: OBJECTIVE
  The authors performed phase I/II clinical trial to evaluate the toxicity and efficacy of carbon ion radiotherapy (C-ion RT) for locally advanced squamous cell carcinoma of the uterine cervix.
  
  
  METHODS
  Between April 2000 and January 2006, 22 patients for Protocol 9902 were treated with C-ion RT. The number of patients with stage IIB, IIIB, and IVA diseases was 1, 18, and 3, respectively. All patients had bulky tumors measuring 4.0-12.0 cm (median 6.2 cm). The whole pelvic dose was fixed at 39.0 GyE for 13 fractions, and additional 15.0 GyE for 5 fractions was given to the gross tumor volume (GTV) and surrounding tissues. With regard to local boost, a dose-escalation study was planned for 2 fractions to GTV. Total dose to the cervical tumor was 64.0-72.0 GyE for 20 fractions.
  
  
  RESULTS
  All patients completed the scheduled therapy and no patient developed Grade 2 or higher acute toxicity. There was no Grade 3 or higher late complications at each dose. The 5-year overall survival rate and local control rate were 50.0% and 68.2%, respectively. Seven out of the 16 patients who received 64.0-68.0 GyE developed local recurrences, but all patients who received 72.0 GyE maintained local control.
  
  
  CONCLUSIONS
  There were no severe acute or late complications in this trial. C-ion RT has the potential to improve the treatment for locally advanced bulky cervical cancer by applying a total dose of 72.0 GyE, with the results lending incentive to further investigations to confirm the therapeutic efficacy.
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan. Electronic address: masaru.wakatsuki@nifty.com.
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: 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, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Ando
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: 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; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D063193:Heavy Ion Radiotherapy / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D013997:Time Factors; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*
keywords: Carbon ion radiotherapy; Cervical cancer; Particle radiation therapy; Phase I/II clinical trial; Radiotherapy