title: Phase I study of daily cisplatin and concurrent radiotherapy in patients with cervical carcinoma.
abstract: OBJECTIVE
  Chemoradiation based on cisplatin is the standard treatment for locally advanced cervical carcinoma; however, the optimal scheduling and dosing have still not been established. This study was conducted to determine the maximum-tolerated dose (MTD) of cisplatin for daily administration during pelvic radiotherapy (RT).
  
  
  METHODS
  Fourteen patients with locally advanced cervical carcinoma and 13 who required postoperative RT were registered. A low dose of cisplatin was given daily concurrently with RT. Cisplatin dosing was started at 6.0 mg/m(2)/day, which was incremented by 0.5 mg/m(2)/day. RT was delivered at 2 Gy/day to a total dose of 50 Gy. The MTD was defined as the dose level immediately below that causing dose-limiting toxicity (DLT) in over one-third of treated patients.
  
  
  RESULTS
  Twenty-five patients were treated with a maximum of six escalating dose levels. In 22/25 patients (88%), cisplatin was administered continuously as planned without interruption. The MTD was determined to be 8 mg/m(2) and the DLT was indicated by the onset of neutropenia.
  
  
  CONCLUSIONS
  Daily cisplatin, at 8 mg/m(2)/day, is a well-tolerated radiosensitizer in cervical carcinoma patients.
authors.affiliation: Department of Reproductive Medicine, Graduate School of Medicine, Chiba University, 1-8-1 Inohana Chuo-ku, Chiba 260-8670, Japan. makira-cib@umin.ac.jp
authors.forename: Akira
authors.initials: A
authors.lastname: Mitsuhashi
authors.forename: Takashi
authors.initials: T
authors.lastname: Uno
authors.forename: Naotake
authors.initials: N
authors.lastname: Tanaka
authors.forename: Kiyomi
authors.initials: K
authors.lastname: Suzuka
authors.forename: Shinichi
authors.initials: S
authors.lastname: Tate
authors.forename: Koji
authors.initials: K
authors.lastname: Yamazawa
authors.forename: Hideo
authors.initials: H
authors.lastname: Matsui
authors.forename: Seiji
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Hisao
authors.initials: H
authors.lastname: Ito
authors.forename: Souei
authors.initials: S
authors.lastname: Sekiya
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002945:Cisplatin / Q000009:adverse effects* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin