| 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 | Yuzuru Niibe, Kazushige Hayakawa, Shinpei Tsunoda, Tadayuki Kanai, Manami Imai, Masahide Arai, Tsutomu Arai, Miwa Kawaguchi, Toshiko Jobo, Yukihiro Hamada, Kazuo Yago, Nobuya Unno, Kitasato Gynecologic Radiation Oncology Group
(Affiliation: Department of Radiology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.)
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| Journal | Japanese journal of clinical oncology
(Jpn J Clin Oncol)
Vol. 37
Issue 1
Pg. 70-2
(Jan 2007)
ISSN: 1465-3621 Japan |
| PMID | 17204507
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Antineoplastic Agents
- Organoplatinum Compounds
- nedaplatin
|
| Topics |
- Adenocarcinoma
(drug therapy, radiotherapy)
- Antineoplastic Agents
(therapeutic use)
- Brachytherapy
- Carcinoma, Squamous Cell
(drug therapy, radiotherapy)
- Combined Modality Therapy
- Dose Fractionation
- Female
- Humans
- Organoplatinum Compounds
(therapeutic use)
- Radiotherapy, High-Energy
- Uterine Cervical Neoplasms
(drug therapy, radiotherapy)
|
