Efficacy Study for Postoperative Chemoradiation Using Triweekly Cisplatin in Cervical Cancer Patients
Efficacy Study for Postoperative Chemoradiation Using Triweekly Cisplatin in Cervical Cancer Patients
The standard postoperative treatment for patients with cervical cancer who had high-risk
 factors is chemoradiation. Generally, weekly cisplatin or 5FU+cisplatin every 3 week have
 been used as chemotherapy regimens of chemoradiation. Based on their experience, the
 investigators hypothesized that tri-weekly cisplatin could be superior to weekly cisplatin.
 Therefore, the investigators are going to perform the efficacy study of postoperative,
 tri-weekly cisplatin chemoradiation for patients with cervical cancer.
Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of
 cervical cancer is favorable, with around 80-90% 5-year survival rate in early stage disease.
 However, advanced disease carries a poor prognosis.

 The standard postoperative treatment for patients with cervical cancer who had high-risk
 factors is chemoradiation. Based on the results of five randomized clinical trials, which
 consistently showed improved survival in patients treated with cisplatin-based CRT, the
 National Cancer Institute (NCI) of the United States announced that 'Strong consideration
 should be given to the incorporation of concurrent cisplatin-based chemotherapy with RT in
 women who require radiation therapy for treatment of cervical cancer' in 1999.

 Although recently reported meta-analysis studies also demonstrated improved local control
 rates and survival with cisplatin-based chemotherapy concurrent to radiation therapy (RT),
 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, as a result of the GOG 165 study, which was closed prematurely because an interim
 analysis found that patients in the 5-FU treatment group were not likely to achieve a better
 outcome, the role of 5-FU (previously popularly included in clinical trials) as a
 radiosensitizer became subject to debate. Furthermore, a clinical trial performed by the NCI
 in Canada comparing pelvic RT alone with weekly cisplatin 40 mg/m2 concurrent to RT failed to
 show improvement of progression free and 5-year survival. While the authors suggested several
 possible reasons for why their study failed to demonstrate a survival benefit with concurrent
 weekly cisplatin 40 mg/m2 chemotherapy, other investigators have tried to find another
 optimal dose and dosing schedule for cisplatin administration.

 In light of the results of the previous clinical trial that indicated 5-FU may not be an
 active radiosensitizer, weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2 remain
 the most popular cisplatin doses and dosing schedules. However, despite the possible
 advantages of tri-weekly cisplatin 75 mg/m2, which offer an increased peak concentration of
 cisplatin and cisplatin administration during brachytherapy, no clinical trials have efficacy
 of tri-weekly cisplatin-based chemotherapy concurrent to RT.

 Therefore, the investigators are going to perform the efficacy study of postoperative,
 tri-weekly cisplatin chemoradiation for patients with cervical cancer.
Inclusion Criteria:

 -  cervical cancer

 -  underwent radical hysterectomy

 -  non-small cell type

 -  FIGO stage 1B - 2A

 -  have one or more risk factors (lymph node involvement, resection margin involvement,
 parametrial involvement)

 -  GOG performance status 0 - 2

 Exclusion Criteria:

 -  Previous history of chemotherapy or radiation

 -  History of other cancer

 -  Hypersensitivity to platinum agents

 -  Pregnancy

 -  Serious medical disease