title: Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501).
abstract: In order to evaluate the safety and efficacy of chemoradiotherapy using nedaplatin for locally advanced uterine cervical carcinoma in Japanese patients, we have started a single-institute phase II trial. Eligibility criteria include: (i) pathologically proven squamous cell carcinoma or adenocarcinoma, (ii) clinical FIGO stage Ib, IIa, or IIb with bulky tumor (> 40 mm) or pelvic lymph node swelling, or (iii) clinical FIGO stage IIIa, IIIb and IVa, (iv) no para-aortic lymph node swelling. A combination of external beam radiation and high dose rate intracavitary irradiation is given. Nedaplatin (30 mg/m2) is intravenously infused on a weekly basis for five times. The primary endpoint is 3-year overall survival, and the secondary endpoints are tumor response, 2-year overall survival, 3-year progression-free survival, acute adverse events, protocol treatment compliance, and late adverse events. We plan to recruit 45 patients within 3 years.
authors.affiliation: Department of Radiology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Niibe
authors.forename: Kazushige
authors.initials: K
authors.lastname: Hayakawa
authors.forename: Shinpei
authors.initials: S
authors.lastname: Tsunoda
authors.forename: Tadayuki
authors.initials: T
authors.lastname: Kanai
authors.forename: Manami
authors.initials: M
authors.lastname: Imai
authors.forename: Masahide
authors.initials: M
authors.lastname: Arai
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Arai
authors.forename: Miwa
authors.initials: M
authors.lastname: Kawaguchi
authors.forename: Toshiko
authors.initials: T
authors.lastname: Jobo
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Hamada
authors.forename: Kazuo
authors.initials: K
authors.lastname: Yago
authors.forename: Nobuya
authors.initials: N
authors.lastname: Unno
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001918:Brachytherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D011882:Radiotherapy, High-Energy; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C053989:nedaplatin