Phase II Study of Concurrent Chemoradiotheapy Using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma (KGROG0501): Final Results.

AIM: This phase II study using nedaplatin evaluated the effectiveness and safely of concurrent chemoradiotherapy for locally advanced uterine cervical carcinoma.

PATIENTS AND METHODS: Patients met the following eligibility criteria,: International Federation of Gynecology and Obstetrics (FIGO) stage Ib, IIa, IIb with bulky tumor (≥40 mm) or pelvic lymph node swelling (≥10 mm), in FIGO stage IIIa, IIIb or IVa. Treatment adopted external radiation therapy combined with intracavitary brachyhtherapy using weekly nedaplain at 30 mg/m2 totaling five cycles. The primary endpoint was 3-year overall survival.

RESULTS: From June 2005 to May 2010, 45 eligible patients with uterine cervical carcinoma were registered. Histopathology was squamous cell carcinoma in 36 and adenocarcinoma in nine. The median follow-up period was 39 months. The 3-year overall survival rate was 73.0% (95% confidence interval=56.2-84.2%). No severe acute or late toxicities occurred.

CONCLUSION: This phase II study showed external radiation therapy combined with intracavitary brachyhtherapy using weekly nedaplain to be effective and safe.