@misc{oai:repo.qst.go.jp:00070748, author = {Karasawa, Kumiko and Wakatuki, Masaru and Ando, Ken and Kato, Shingo and Kiyohara, Hiroki and Kamada, Tadashi and 唐澤 久美子 and 若月 優 and 安藤 謙 and 加藤 眞吾 and 清原 浩樹 and 鎌田 正}, month = {May}, note = {Objective : A clinical trial of carbon ion radiotherapy for gynecological melanoma was conducted under the Phase I/II clinical trial to assess the toxicity and efficacy. \nMethods : The eligibility criteria for enrollment in this study were (1) histologically proven malignant melanoma, (2) a localized measurable tumor in gynecological region, (3) at least a 5mm gap between the tumor and radiosensitive organs, including bowel and bladder, and (4) a expected prognosis of more than 6 months. In principle, tumors and surrounding areas were irradiated 3.6 GyE per fraction up to the total dose of 57.6 GyE in 16 fractions, 4 times a week. Toxicities were assessed weekly and graded according to NCI-CTCAE ver.4.0. Treatment response was assessed at 3 month after treatment completion. Statistical analysis of survival was calculated using the Kaplan-Meier method. \nResults : A series of 21 gynecological melanoma patients were treated with carbon ion radiotherapy between November 2004 and October 2011. The age ranged from 51 to 80 with a median of 71. The tumor sites were vagina in 13, vulva in 3, uterine cervix in 3 and vagina and vulva in 2. The clinical stage was stage I in 3, stage II in 9, stage III in 5, stage IVB in 1 and 3 patients had local recurrent tumor. The irradiated dose was 57.6 GyE in 20 and 64 GyE in 1. Twelve patients were treated with DAV-Feron regime (DTIC, ACNU, VCR, IFN-) and 4 patients treated with IFN- only for induction and /or adjuvant therapy. One patient had used IFN- during radiotherapy. Greater than 2 acute toxicities were observed with regard to grade 3 skin reaction in 2, grade 2 skin reaction in 4 and grade 2 urinary tract reaction in 1. The median follow-up times were 15 months (range 3-53 months) in all patients, 15 months (range 3-43 months) in the living and 16 months (range 11-53 months) in the dead. One patient who had been treated concurrent IFN- developed sepsis induced by urinary tract infection after 3 months from the completion of radiotherapy. Thirteen patients have recurred, in-field in 3, marginal field in 3, regional lymph node in 6 and distant in 6. All T1 tumors and all vulval tumors were locally controlled. Ten of 21 patients were dead, one was intercurrent disease and other 9 were of melanoma. The 2-year local control rate, disease free rate and overall survival rate were 71%, 38% and 53% respectively. \nConclusions : Carbon ion radiotherapy is as effective as surgery for gynecological melanoma., 51st Annual Meeting of Particle Therapy Co-Operative Group}, title = {Carbon Ion Radiotherapy For Gynecological Melanoma}, year = {2012} }