Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501).
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.
Niibe
Yuzuru
Y
Department of Radiology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Hayakawa
Kazushige
K
Tsunoda
Shinpei
S
Kanai
Tadayuki
T
Imai
Manami
M
Arai
Masahide
M
Arai
Tsutomu
T
Kawaguchi
Miwa
M
Jobo
Toshiko
T
Hamada
Yukihiro
Y
Yago
Kazuo
K
Unno
Nobuya
N
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*
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C053989:nedaplatin