title: The phase I/II clinical study of carbon ion therapy for cancer of the uterine cervix.
abstract: OBJECTIVE
  The phase I/II clinical study of carbon beam therapy was undertaken for 31 cases of advanced cervical cancer of stages IIIB and IVA from June 1995 to November 1997. The main purpose was to determine clinically useful fraction doses without severe acute reaction of normal tissues and to assess tumor control dose levels achievable without significant normal tissue toxicity.
  
  
  METHODS
  The treatment was given with four fixed fractions per week (24 fractions over 6 weeks) and was initiated with a fraction dose of 2.2 Gray equivalent (GyE), and the dose was increased as 2.4 GyE, 2.6 GyE, 2.8 GyE, and 3.0 GyE. Consequently, the total dose initiated was 52.8 GyE, to increase up to 72.0 GyE in 4.8-GyE increments in the dose-escalation fashion. Thirty patients with eligible advanced cervical cancers consisting of 27 squamous cell carcinomas and three adenocarcinomas were analyzed.
  
  
  RESULTS
  Acute response of normal tissues was less than with photon treatment until fraction doses of 2.8 GyE were administered, and patients finished treatment with comfortable conditions. Severe late complications occurred in the two patients who received more than 67.2 GyE. The 2-year cumulative survival rate and the local control rate of 27 patients with squamous cell carcinoma were 61.5% and 59.3%, respectively. According to stages, the 2-year survival rates of stage IIIB and IVA patients were 54.4% and 75.0%, respectively. The 2-year local control rates of stage IIIB and IVA patients were 52.6% and 75.0%, respectively.
  
  
  CONCLUSIONS
  These results indicated that the disease control seems to be relatively better for very advanced disease and with dose escalation treatment. Local control was not significantly correlated with total dose and tumor volume. The results of the present study, despite small numbers and short observation, suggest that an adequate fraction dose for pelvis fields is 2.8 to 3.0 GyE and that the carbon beam therapy might be advantageous for advanced cervical cancer.
authors.affiliation: Division of Radiation Medicine, Center of Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Nakano
authors.forename: M
authors.initials: M
authors.lastname: Suzuki
authors.forename: A
authors.initials: A
authors.lastname: Abe
authors.forename: Y
authors.initials: Y
authors.lastname: Suzuki
authors.forename: S
authors.initials: S
authors.lastname: Morita
authors.forename: J
authors.initials: J
authors.lastname: Mizoe
authors.forename: S
authors.initials: S
authors.lastname: Sato
authors.forename: T
authors.initials: T
authors.lastname: Miyamoto
authors.forename: T
authors.initials: T
authors.lastname: Kamada
authors.forename: H
authors.initials: H
authors.lastname: Kato
authors.forename: H
authors.initials: H
authors.lastname: Tsujii
mesh_terms: D000328:Adult; D000368:Aged; D002244:Carbon / Q000627:therapeutic use*; D005260:Female; D063193:Heavy Ion Radiotherapy; D020450:Heavy Ions / Q000009:adverse effects; D006801:Humans; D018499:Linear Energy Transfer; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D002244:Carbon