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- Title
Phase II Study of Radiation Therapy Combined with Weekly Nedaplatin in Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501).
- Authors
Niibe, Yuzuru; Hayakawa, Kazushige; Tsunoda, Shinpei; Kanai, Tadayuki; Imai, Manami; Arai, Masahide; Arai, Tsutomu; Kawaguchi, Miwa; Jobo, Toshiko; Hamada, Yukihiro; Yago, Kazuo; Unno, Nobuya
- 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.
- Publication
Japanese Journal of Clinical Oncology, 2007, Vol 37, Issue 1, p70
- ISSN
0368-2811
- Publication type
Article
- DOI
10.1093/jjco/hyl153