Background: This paper describes about a study protocol of phase I/II multicenter prospective clinical trial\nevaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally\nadvanced uterine cervical cancer patients.\nMethods and design: Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical\ncarcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy\nis 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m2), followed by\n24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed\nagain within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the\nsecondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients\nexperienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In\nphase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with\nhistorical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival\nof the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT.\nDiscussion: The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced\ncervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique.
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