Trial Information

A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients

Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of
cervical cancer is favorable, with an approximately 80-90% 5-year survival rate in
early-stage disease. However, advanced disease carries a poor prognosis.

Current standard treatment for locally advanced cervical cancer, which is not eligible for
surgical treatment, is cisplatin-based concurrent chemoradiation. On the basis of the
results of five randomized clinical trials, which consistently showed improved survival in
patients treated with cisplatin-based chemoradiation, the U.S. National Cancer Institute
(NCI) announced in 1992 that "Strong consideration should be given to the incorporation of
concurrent cisplatin-based chemotherapy with radiotherapy in women who require radiotherapy
for treatment of cervical cancer".

Although recently reported meta-analyses also demonstrated improved local control rates and
survival with cisplatin-based chemotherapy concurrent with radiation, the optimal cisplatin
dose and dosing schedule are still undetermined.

Among the previous five randomized clinical trials, two trials performed by the Gynecologic
Oncology Group (GOG) used weekly cisplatin 40 mg/m2 while the other three trials used
tri-weekly cisplatin at a dosage range of 50 mg/m2 to 75 mg/m2 combined with 5-fluorouracil
(5-FU). Despite the diversity in cisplatin dose and dosing schedules, weekly cisplatin at a
dose of 40 mg/m2 concurrent to RT is widely accepted as the standard regimen of CRT because
of its convenience, equal effectiveness, and favorable toxicity in comparison to other 5-FU
combined regimens.

However weekly cisplatin regimen needs frequent hospital visits and had a poor compliance
profile in korea. With weekly cisplatin regimen, planned treatment was not completed in 58%
patients adn treatment delayed in 29% patient. among these patients, 9% patients were not
related associated toxicities.

To overcome toxicities and poor compliance of weekly regimen, the investigators tried to
evaluate the efficacy and feasibility of CCRT with cisplatin 75mg/m2 every 3 weeks.