title: Multi-institutional phase II clinical study of concurrent chemoradiotherapy for locally advanced cervical cancer in East and Southeast Asia.
abstract: OBJECTIVE
  To evaluate the toxicity and efficacy of concurrent chemoradiotherapy using weekly cisplatin for patients with locally advanced cervical cancer in East and Southeast Asia, a multi-institutional Phase II clinical study was conducted among eight Asian countries.
  
  
  METHODS
  Between April 2003 and March 2006, 120 patients (60 with bulky Stage IIB and 60 with Stage IIIB) with previously untreated squamous cell carcinoma of the cervix were enrolled in the present study. Radiotherapy consisted of pelvic external beam radiotherapy (total dose, 50 Gy) and either high-dose-rate or low-dose-rate intracavitary brachytherapy according to institutional practice. The planned Point A dose was 24-28 Gy in four fractions for high-dose-rate-intracavitary brachytherapy and 40-45 Gy in one to two fractions for low-dose-rate-intracavitary brachytherapy. Five cycles of weekly cisplatin (40 mg/m(2)) were administered during the radiotherapy course.
  
  
  RESULTS
  All patients were eligible for the study. The median follow-up was 27.3 months. Of the 120 patients, 100 (83%) received four or five cycles of chemotherapy. Acute Grade 3 leukopenia was observed in 21% of the patients, and Grade 3 gastrointestinal toxicity was observed in 6%. No patient failed to complete the radiotherapy course because of toxicity. The 2-year local control and overall survival rate for all patients was 87.1% and 79.6%, respectively. The 2-year major late rectal and bladder complication rate was 2.5% and 0%, respectively.
  
  
  CONCLUSIONS
  The results have suggested that concurrent chemoradiotherapy using weekly cisplatin is feasible and effective for patients with locally advanced cervical cancer in East and Southeast Asia.
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan. s_kato@nirs.go.jp
authors.forename: Shingo
authors.initials: S
authors.lastname: Kato
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ohno
authors.forename: Kullathorn
authors.initials: K
authors.lastname: Thephamongkhol
authors.forename: Yaowalak
authors.initials: Y
authors.lastname: Chansilpa
authors.forename: Yang
authors.initials: Y
authors.lastname: Yuxing
authors.forename: C R Beena
authors.initials: CR
authors.lastname: Devi
authors.forename: Anita Z
authors.initials: AZ
authors.lastname: Bustam
authors.forename: Miriam J C
authors.initials: MJ
authors.lastname: Calaguas
authors.forename: Rey H
authors.initials: RH
authors.lastname: de los Reyes
authors.forename: Chul-Koo
authors.initials: CK
authors.lastname: Cho
authors.forename: To Anh
authors.initials: TA
authors.lastname: Dung
authors.forename: Nana
authors.initials: N
authors.lastname: Supriana
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Mizuno
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Tsujii
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001208:Asia; D001918:Brachytherapy / Q000379:methods; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000627:therapeutic use; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008875:Middle Aged; D009503:Neutropenia / Q000209:etiology; D011879:Radiotherapy Dosage; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin