• Title/Summary/Keyword: Clinical Trial

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A Study on the Moisturizing Effect and Preparation of Liquid Crystal Structures Using Sucrose Distearate Emulsifier (슈크로오스디스테아레이트를 사용한 액정구조의 생성과 보습효과에 관한 연구)

  • Kwak, Myeong-Heon;Kim, In-Young;Lee, Hwan-Myung;Park, Joo-Hoon
    • Journal of the Korean Applied Science and Technology
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    • v.33 no.1
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    • pp.1-12
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    • 2016
  • This study is to make the liquid crystalline structure using sucrose distearate (Sucro-DS) emulsifier to create the hydrophilic type oil-in-water (O/W) emulsion, the droplets of the emulsion having a structure of a multi-lamellar structure. We have studied the physicochemical properties of Sucro-DS using those techniques. And it has been studied in the emulsion performance. In order to form the liquid crystalline structure applying 3 wt% of Sucro-DS, 5 wt% of glycerin, 5 wt% of squalane, 5 wt% of capric/caprylic triglyceride, 3wt% of cetostearyl alcohol, 1wt% of glyceryl mono-stearate, 78 wt% of pure water in mixture having the lamellar structure of stable multi-layer system was found to formed. By applying them, they were described how to create an unstable active material encapsulated cream. Further, the moisturizing cream was studied using this technique. It reported the results to the skin improvement effect by the human clinical trials. The pH range to produce a stable liquid crystal phase using a Sucro-DS was maintained in 5.2~7.5. In order to increase the stability of the liquid crystal, it was when behenyl alcohol containing 3 wt%, the hardness at this time was 13 kg/mm,min. Viscosity of the same amount was 25,000mPas/min. After a test for the effects of the emulsions, the concentration of 6 wt% Sucro-DS is that was appropriate, the particle size of the liquid crystal was 4~6mm. It was observed through a microscope analysis, reliability of the liquid crystal changes for 3 months was found to get stable at each $4^{\circ}C$, $25^{\circ}C$ and $45^{\circ}C$. In clinical trial test, before applying a moisturizing effect it was $13.4{\pm}7%$. Moisturizing cream liquid crystal was not formed in $14.5{\pm}5%$. Therefore, applying than ever before could see the moisture about 8.2% was improved. On the other hand, it was the moisturizing effect of the liquid cream is $19.2{\pm}7%$. The results showed that 43.3% improvement than that previously used. Applications fields, Sucro-DS emulsifier used liquid cream, lotion, eye cream and a variety of formulations can be developed, as well as the cosmetics industry is expected to be wide fields in the application of the external preparation for skin emulsion technology in the pharmaceutical industry and pharmaceutical industry.

The Effects of Weighted Vest During Task-Oriented Training on Gross Motor Performance and Balance Abilities of Children With Spastic Diplegia : A Randomized Clinical Trial Study (경직형 양마비 아동의 과제지향훈련 시 무게조끼 적용이 대동작 수행력과 균형 능력에 미치는 영향: 무작위배정 위약비교 연구)

  • Kwon, Hae-Yeon
    • The Journal of Korean Academy of Sensory Integration
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    • v.15 no.2
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    • pp.46-65
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    • 2017
  • Objective : The purpose of this research is to find clinical effects of application of weighted vest during task-oriented training focused on gross motor performance and balance abilities of children with spastic diplegia. Methods : 34 subjects were divided by simple random sampling into two groups; experimental group (male : 9, female : 8, average age : 8.12) and placebo group (male : 9, female : 9, average age : 7.53). Both two groups underwent to 40 minute intervention, twice a week for 12 weeks. The intervention was task-oriented training focused on facilitating closed kinematic chain and multi-joint functional movement pattern. During the training, the experimental group received loaded-resistance weighted vest and placebo group also received weighted vest but without loaded-resistance. Participants in both groups underwent 8 to 10 reps of the task-oriented training and there were 3 minutes break time between tasks. There were pre-test of gross motor performance and balance abilities, and two times of post-tests were performed upon 6 weeks and 12 weeks after the intervention completed. And in final, an additional follow-up test was performed 12 weeks after the evaluation was finished in order to find any difference between the two groups over time. Results : There was significant difference in Gross Motor Performance Measure (GMPM) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). There was significant difference in Pediatric Berg's Balance Scale (PBS) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). Conclusion : Based on the results in this study, it is proposed that application of weighted vest into task-oriented training to facilitating closed kinematic chain and multi-joint movement can improve gross motor performance and balance abilities of children with cerebral palsy.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Effect of Magnesium Administration on Preventing Arrhythmias after Coronary Artery Bypass Graft (관상동맥 우회술 후 마그네슘 투여가 심 부정맥을 예방하는 효과)

  • Kim, Jun-Hyun;Song, Hyun;Kim, Yong-Hee;Lee, Eun-Sang;Lee, Jay-Won;Song, Myung-Kun
    • Journal of Chest Surgery
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    • v.31 no.4
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    • pp.339-345
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    • 1998
  • Arrhythmias are common after cardiac surgery and are multifactorial. Intravenous magnesium administration reduces the frequency of ventricular arrhythmias in patient with symptomatic heart failure or acute myocardial infarction. This study was designed to evaluate the role of magnesium in preventing PVCs(premature ventricular contractions) occurred frequently after coronary artery bypass graft(CABG). 50 consecutive patients were prospectively entered into a randomized trial to determine the efficacy of postoperative magnesium therapy on the incidence of cardiac arrhythmias after elective coronary artery bypass graft. The patients underwent coronary angiography, echocardiography, electrocardiography and clinical laboratory study preoperatively. Continuous electrocardiographic monitoring was done and magnesium level was checked 0, 3, 6, 12, 18, 24, 36, 48, 60 and 72 hours postoperatively. Study group of 25 patients were given 4g of magnesium continuously over the first 24 hours and then 2g/24hours from 25 to 72 hours. The clinical characteristics of both groups were similar(p<0.05). The preoperative mean serum magnesium concentration was similar in both study group, 1.59mg/dl and control group, 1.71mg/dl. The mean postoperative serum magnesium concentration in study group elevated significantly over postoperative 12hours through 36hours(p<0.05). The postoperative mean serum magnesium concentration in control group declined and remained significantly depressed over immediate postoperation through 72hours. The mean serum magnesium concentration was significantly greater in the study group compared with the control group over postoperative 3hours through 72hours(p<0.05). There was a significant decrease in the incidence of arrhythmias such as PVCs(p<0.01) which might jeopardize hemodynamics. There were no recognized adverse effects of magnesium Administration. In conclusion, prophylactic magnesium administration seems to lessen the incidence and severity of rrhythmias after coponary artery bypass graft.

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New Whitening Agent : Selina-4(14), 7(11)-dien-8-one (신규 미백제 : Selina-4(14), 7(11)-dien-8-one)

  • Kim, Cheong-Taek;Chang, Yun-Hee;Lee, Sang-Hwa;Kang, Sang-Jin;Cho, Wan-Goo
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.31 no.1 s.49
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    • pp.17-23
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    • 2005
  • We had previously reported that Selina (selina-4(14), 7(11)-dien-8-one) was isolated from methanol extract of Afractylodes rhizome and has strong whitening activity in B16 melanoma cells. In this report, we demonstrated its action mechanism in melan-a cells, non-tumorigenic melanocytes. We also investigated the clinical efficacy of cosmetic preparation containing Selina. Selina reduced the melanin synthesis of Melan-a cells by $50\%$ at a concentration of $10 {\mu}g/mL$ without any apparent cytotoxicity. We also found that the treatment of cells with Selina decreased tyrosinase activity by $60\%$ at a concentration of $10 {\mu}g/mL$ but Selina was not a direct inhibitor of tyrosinase activities. To elucidate the action mechanism of Selina, we investigated the changes in mRNA and protein level of tyrosinase, TRP-1 and TRP-2 using RT-PCR and western blotting, respectively. As a result, the mRNA and protein level of tyrosinase were markedly reduced at $10 {\mu}g/mL$ of Selina without any effect on TRP-1 and TRP-2. These results suggest that Selina exerts its whitening effect mainly through regulating expression of tyrosinase. A 7 week-clinical trial using formulation containing $0.2\%$ selina-4(14), 7(11)-dien-8-one with 20 volunteers resulted in statistically significant whitening effect (p < 0.05), without any adverse effect. Based on these results, Selina (selina-4(14), 7(11)-dien-8-one) can be s useful and safe ingredient for the cleanness and brightness of skin.

Influence of crown-to-implant ratio of short vs long implants on implant stability and marginal bone loss in the mandibular single molar implant (하악 구치 단일임플란트 수복에서 임플란트 길이에 따른 치관-임플란트 비율이 임플란트안정성 및 변연골소실에 주는 영향)

  • Baek, Yeon-Wha;Kim, Bongju;Kim, Myung-Joo;Kwon, Ho-Beom;Lim, Young-Jun
    • Journal of Dental Rehabilitation and Applied Science
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    • v.34 no.4
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    • pp.280-289
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    • 2018
  • Purpose: The purpose of this randomized clinical trial is to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and peri-implant marginal bone loss (MBL). Materials and Methods: 46 patients with single tooth missing in the posterior molar region of the mandible were included in this study. 19 implants (CMI IS-III $active^{(R)}$ long implant) of 5.0 mm diameter and 10 mm length were installed for the control group, while 27 implants (CMI IS-III $active^{(R)}$ short implant) of 5.5 mm diameter and 6.6, 7.3 or 8.5 mm length were placed for the experimental group. Each implant was inserted and immediately loaded using the digitally pre-fabricated surgical template and provisional restoration. The CAD-CAM monolithic zirconia crown was fabricated at 3 months after the surgery as a definitive restoration. The ISQ value and the MBL was measured at 48 weeks after the surgery. The correlation between the C/I ratio, MBL, and secondary implant stability was analyzed. Results: Successful results in terms of ISQ and MBL were achieved with both groups. There was no significant difference between the groups in terms of ISQ values and MBL at 48 weeks after the surgery (P > 0.05). No significant correlation was found between the C/I ratio and secondary stability as well as the C/I ratio and the MBL (P > 0.05). Conclusion: The influence of C/I ratio in both groups was not shown on the stability nor the marginal bone loss in implants supporting single crown of the mandible. Short implant could be a preferable alternative option in the reduced bone height mandible under the limited condition despite its higher C/I ratio.

A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.315-327
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    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

Clinical Efficacy of Erdosteine in Patients with Acute or Chronic Bronchitis -A Randomized, Double Blind, Comparative Study vs. Ambroxol- (급.만성 기관지염 환자에서 엘도스$^{(R)}$(Erdosteine)의 임상효과 -염산 암브록솔과의 무작위 이중맹검 비교시험-)

  • Kim, Seok-Chan;Lee, Sang-Hoak;Song, So-Hyang;Kim, Young-Kyoon;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1296-1307
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    • 1997
  • Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

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A Prospective Randomized Trial Comparing the Seciuence of Adiuvant Chemotherapy and Radiotherapy following Curative Resection of Stage II, III Rectal Cancer (직장암의 근치적 수술 루 방사선치료와 화학요법의 순서에 대한 고찰 -전향적 무작위 3상 임상연구 중간 결과 보고-)

  • Kim Kyoung Ju;Kim Jong Hoon;Choi Eun Kyung;Chang Hyesook;Ahn Seung Do;Lee Je Hwan;Kim Jin Cheon;Yu Chang Sik
    • Radiation Oncology Journal
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    • v.18 no.1
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    • pp.17-25
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    • 2000
  • Purpose : To evaluate the side effects, pattern of failure, and survival rate according to the sequence of postoperative adjuvant radiotherapy and chemotherapy, patients with stages II and III rectal cancer who had undergone curative resection were randomized to 'early radiotherapy group (arm I)' or' late radiotherapy group (arm II)', then we intend to determine the most effective sequence of the radiotherapy and chemotherapy. Materials and Methods . From January 1996 to March 1999, 313 patients with curatively resected stages II and III rectal cancer have been randomized to' early' or' late' radiation therapy group and received combined chemotherapy (5-FU 375 mg/m$^{2}$/day, ieucovorin 20 mg/m$^{2}$, IV bolus daily Dl-5, 8 cycles) and radiation therapy (whole pelvis with 45 Gy/25 fractions/s weeks). Arm I received radiation therapy from day 1 with first cycle of chemotherapy and arm II received radiation therapy from day 57 with third cycle of chemotherapy after completion of first two cycles. Preliminary analysis was peformed with 228 patients registered up to Jun 1998. Two out of the 228 patients were excluded because of double primary cancer. Median follow-up period was 23 months. Results :Local recurrence occurred in 11 patients (9.7$\%$) for arm I and 9 patients (8$\%$) for arm 11. There was no significant difference between both groups ( p=0.64). However, distant metastasis was found in 22 patients (19.5$\%$) for arm I and 35 patients (31.0$\%$) for arm II and which showed statistically significant difference between the two groups ( p=0.046). And neither 3-year disease-free survival (70.2$\%$ vs 59.2$\%$, p=0.2) nor overall survival (89.4$\%$ vs 88.0$\%$, p=0.47) showed significant differences. The incidence of leukopenia during radiation therapy and chemotherapy was 78.3$\%$ and 79.9$\%$ respectively but leukopenia more than RTOG grade 3 was only 2.1$\%$ and 6.0$\%$ respectively. The incidence of diarrhea more than 10 times per day was significantly higher in the patients for arm I than for arm II (71.2$\%$ vs 41.6$\%$, p=0.02) but this complication was controlled with supportive cares. Conclusion : Regardless of the sequence of postoperative adjuvant radiation therapy and chemotherapy after curative resection for rectal cancer, local recurrence rate was low with combined chemoradlotherapy. But distant metastasis rate was lower in early radiation therapy group than in late radiation therapy group and the reason is unclear. Most patients completed these treatments without severe complication, so these were thought to be safe treatments but the treatment compliance should be improved.

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Low Dose Cisplatin as a Radiation Sensitizer in Management of Locally Advanced Scluamous Cell Carcinoma of the Uterine Cervix : Evaluation of Acute Toxicity and Early Response (국소 진행된 자궁경부암의 방사선치료와 저용량 cisplatin 항암요법 동시치료시 급성독성 밀 초기반응 평가)

  • Kim Hunjung;Cho Young Kap;Kim Chulsu;Kim Woo Chul;Lee Sukho;Loh J K
    • Radiation Oncology Journal
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    • v.17 no.2
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    • pp.113-119
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    • 1999
  • Purpose : To evaluate possible acute toxicity and early response of concurrent radiation therapy and low dose daily cisplatin as a radiosensitizer in patients with locally advanced uterine cervical carcinomas. Materials and Method : From December 1996 to January 1999, 38 previously untreated Patients with locally advanced squamous cell carcinoma of the uterine cervix (from stage IIB to stage IIIB) were treated at Inha University Hospital. All patients underwent standard pretreatment staging Procedures after the initial evaluation by gynecologists and radiation oncologists. Sixteen Patients with huge cervical mass (>4 cm) were submitted to the group treated with concurrent radiation therapy and low dose daily cisplatin while the remainder was treated with radiation therapy alone. Radiation therapy consisted of 4500 cGy external beam irradiation to whole pelvis (midline block after 3000 cGy), 900$\~$1000 cGy boost to involved parametrium, and high dose-rate intracavitary brachytherapy (a total dose of 3000$\~$3500 cGy/500 cGy per fraction to point A, twice per week). In the group treated with low dose cisplatin concurrently, 10 mg of daily intravenous cisplatin was given from the 1st day of radiation therapy to the 20th day of radiation therapy. Acute toxicity was measured according to expanded common toxicity criteria of the NCI (C) Clinical Trials. Early response data were analyzed at minimum 4 weeks' follow-up after completion of the treatment protocol. Results: Hematolgic toxici쇼 was more prominent in patients treated with radiation therapy and cisplatin. Six of 16 patients (37.5$\~$) treated with radiation therapy and cisplatin and one of 22 patients (4.5$\~$) treated with radiation therapy alone experienced grade 3 leukopenia. In Fisher's exact test, there was statistically significant difference between two groups regarding leukopenia (P=0.030). There was no apparent difference in the frequency of gastrointestinal and genitourinary toxicity between two groups (P=0.066). Three of 16 patients (18.7$\~$) treated with radiation therapy and cisplatin and two of 22 patients (9.1$\~$) treated with radiation therapy alone experienced more than 5 kg weight loss during the treatment. There was no statistically significant difference on weight loss between two groups (P=0.63). Two patients on each group were not evaluable for the early response because of incomplete treatment. The complete response rate at four weeks' follow-up was 80$\~$(16/20) for the radiation therapy alone group and 78$\~$ (11/14) for the radiation therapy and cisplatin group. There was no statistically significant difference in early response between two treatment groups (P=0.126). Conclusion : This study led to the conclusion that the hematologic toxicity from the treatment with concurrent radiation therapy and low dose daily cisplatin seems to be more prominent than that from the treatment of radiation therapy alone. There was no grade 4 hematologic toxicity or mortality in both groups. The hematologic toxicity in both treatment groups seems to be well managable modically. Since the risk factors were not balanced between two treatment groups, the direct comparison of early response of both groups was not possible. However, preliminary results regarding early response for patients with bulky cervical tumor mass treated with radiation therapy and low dose daily cisplatin was encouraging. Longer follow-up is necessary to evaluate the survival data. A phase III study is needed to evaluate the efficacy of concurrent daily low dose cisplatin with radiation therapy in bulky cervical cancer.

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