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Japanese Journal of Clinical Oncology Advance Access published online on January 4, 2007
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyl153
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© 2007 Foundation for Promotion of Cancer Research

Phase II Study of Radiation Therapy Combined with Weekly Nedaplatin in Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501)

Yuzuru Niibe1,, Kazushige Hayakawa1, Shinpei Tsunoda2, Tadayuki Kanai2, Manami Imai2, Masahide Arai2, Tsutomu Arai2, Miwa Kawaguchi2, Toshiko Jobo2, Yukihiro Hamada3, Kazuo Yago3, Nobuya Unno2 for the Kitasato Gynecologic Radiation Oncology Group

1 Department of Radiology, Kitasato University School of Medicine, Sagamihara, Kanagawa
2 Department of Obstetrics and Gynecology, Kitasato University School of Medicine, Sagamihara, Kanagawa
3 Division of Pharmacology, Kitasato University Hospital, Sagamihara, Kanagawa, Japan

For reprints and all correspondence: Yuzuru Niibe, Department of Radiology, Kitasto University School of Medicine, 1-15-1, Kitasato, Sagamihara, Kanagawa 225-8555, Japan. E-mail: joe-n{at}hkg.odn.ne.jp

Received December 20, 2005; accepted April 11, 2006

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.

Key Words: chemoradiotherapy • locally advanced uterine cervical carcinoma • nedaplatin • phase II study


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