Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501)

Jpn J Clin Oncol. 2007 Jan;37(1):70-2. doi: 10.1093/jjco/hyl153. Epub 2007 Jan 4.


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 types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy
  • Adenocarcinoma / radiotherapy
  • Antineoplastic Agents / therapeutic use*
  • Brachytherapy
  • Carcinoma, Squamous Cell / drug therapy
  • Carcinoma, Squamous Cell / radiotherapy
  • Combined Modality Therapy
  • Dose Fractionation, Radiation
  • Female
  • Humans
  • Organoplatinum Compounds / therapeutic use*
  • Radiotherapy, High-Energy
  • Uterine Cervical Neoplasms / drug therapy*
  • Uterine Cervical Neoplasms / radiotherapy*


  • Antineoplastic Agents
  • Organoplatinum Compounds
  • nedaplatin