title: A phase I study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma.
abstract: OBJECTIVE
  To establish the maximum tolerated dose and dose-limiting toxicity of chemoradiation with paclitaxel (PTX) and cisplatin (CDDP) for patients with local symptoms due to unresectable primary advanced or locally recurrent gastric adenocarcinoma located at left-upper abdomen.
  
  
  METHODS
  Chemotherapy consisted of PTX at escalating doses of 40-80 mg/m(2) per day and CDDP at escalating doses of 20-25 mg/m(2) per day on days 1, 15, and 29. Concurrent radiation was administered up to a dose of 45 Gy for 5 weeks.
  
  
  RESULTS
  A total of nine patients were enrolled, of which six were into level 1 (PTX 60 mg/m(2) and CDDP 20 mg/m(2)) and three into level -1 (PTX 50 mg/m(2) and CDDP 20 mg/m(2)). At level 1, one patient developed grade 3 fatigue, and the other experienced grade 5 DIC, grade 5 pneumonia, grade 4 thrombocytopenia, grade 3 hyponatremia, and grade 3 esophagitis as dose-limiting toxicities. A palliative effect was observed in eight of nine patients; six of six patients at level 1 and two of three at level -1.
  
  
  CONCLUSIONS
  PTX 50 mg/m(2) and CDDP 20 mg/m(2) given biweekly with concurrent radiation therapy of 45 Gy were well tolerated.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815, Japan, yoshikawat@kcch.jp
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
authors.forename: Naoki
authors.initials: N
authors.lastname: Hirabayashi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.forename: Naoki
authors.initials: N
authors.lastname: Nagata
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kodera
authors.forename: Naoto
authors.initials: N
authors.lastname: Takahashi
authors.forename: Koji
authors.initials: K
authors.lastname: Oba
authors.forename: Masayuki
authors.initials: M
authors.lastname: Kimura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ishikura
authors.forename: Yumi
authors.initials: Y
authors.lastname: Miyashita
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D000368:Aged; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000532:radiotherapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010166:Palliative Care / Q000379:methods*; D011878:Radiotherapy / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin