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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices: Dental X-ray Equipment (치과용엑스선장치의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Lee, Jun-Ho;Park, Chang-Won
    • Journal of radiological science and technology
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    • v.39 no.4
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    • pp.651-660
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    • 2016
  • Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

Preliminary Result in Patients with Primary Hepatoma Treated by Stereotactic Radiotherapy (원발성 간암에 대한 정위방사선치료의 예비결과)

  • Kang Ki Mun;Choi Ihl Bohng;Kim In Ah;Choi Byung Ock;Kang Young Nam;Chai Gyu Young;Han Sung Tae;Chung Gyu Won
    • Radiation Oncology Journal
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    • v.19 no.1
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    • pp.34-39
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    • 2001
  • Purpose : It is not common to evaluate the response of the fractionated stereotactic radiotherapy (SRT) to primary hepatoma as compared with conventional radiotherapy. The purpose of the study was to take the preliminary result on the clinical trial of primary hepatoma by SRT. Materials and Methods : From July 1999 to March 2000, thirty three patients were hospitalized in the St. Mary's Hospital, and treated with SRT for extracranial tumors. Among them, 13 patients were diagnosed to primary hepatoma and then applied by frameless SRT using 6 MV linac accelerator. There were 12 male and 1 female patients. They had the age of $ 44\~66$ year old (median : 59) and the tumor size of $10\~825\;cc$ (median : 185 cc). SRT was given to them $3\~5$ fractions a week (5 Gy/fraction, $90\%$ isodose line) for $2\~3$ weeks. Median dose of SRT was 50 Gy and the range was $30\~50\;Gy$. Results : Follow-up period ranged from 3 months to 13 months with median of 8 months. After treating SRT to thirteen patients with primary hepatoma, the response of the tumor was examined by abdominal CT : they are classified by 1 complete regression $(7.7\%)$, 7 partial regression $(53.8\%)$, 4 minimal regression $(30.8\%)$, 1 stable disease $(7.7\%)$. The positive responses more than partial remission were 8 patients $(61.5\%)$ after the treatment. The level of serum alpha-fetoprotein (AFP) after the treatment as compared with pretreatment had been $92.3\%$ decreased. There was no severe complication except dyspepsia $84.6\%$, mild nausea $69.2\%$, transient decreased of hepatic function $15.4\%$ and fever $7.7\%$. Conclusion : SRT to the patients with primary hepatoma was potentially suggested to become the safe and more effective tool than the conventional radiotherapy even though there were relatively short duration of follow-up and small numbers to be tested.

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A Model to Measure the Success of a Web-based Information System at a Government Agency - the Chungwadae Case (공공기관 업무관리시스템 성과평가 모형 개발에 관한 연구: 청와대 업무관리시스템(e지원시스템)을 중심으로)

  • Bae, Lee-Chul;Hong, Il-Yoo
    • Asia pacific journal of information systems
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    • v.18 no.1
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    • pp.97-115
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    • 2008
  • Introduction The e-government is concerned with using Internet and Web technologies to exchange information and services with citizens, businesses and other related organizations, and it centers on three functions, namely informational, interactive, and transactional [UN, 2001]. Many developed countries like the U.S. have been actively involved in e-government projects, since they enable both more effective public services for citizens and more efficient internal operations. Korea is among these leading countries that are planning to leverage computer and communication technologies to provide for integration of work processes and information as well as convenient access to information and services. For this reason, evaluating e-government projects is becoming a crucial issue for both researchers and policy-makers. However, most research to date has primarily focused on a model of success of an e-government system designed for citizens, overlooking internal systems specifically created for employees working in a public organization. This paper is intended to propose a model to measure the success of a Web-based information system designed for use by internal users at Chungwadae, the executive branch of Korea's central government. The paper is also aimed at applying the model to the assessment of the present system being used at Chungwadae in comparison with the preceding system. Evaluating an e-Government System The most widely cited model of information systems success today is that of DeLone and McLean[1992, 2003, 2004]. The original model states that the success of an information system can be measured using six dimensions, including system quality, information quality, use, user satisfaction, individual impact, and organizational impact. Although the ultimate success of an information system may be reflected in the impact that the system has upon individuals as well as an organization, aspects of using the system such as system use and user satisfaction can play an important role in determining the system success, because the system would be a sheer failure if users don't like and use the system. As a response to criticisms given by numerous researchers, the authors adapted their model to fit the emerging Web-based environment. The revised model[DeLone and McLean, 2003] they offered included an additional quality dimension, namely service quality, and combined individual and organizational impacts into net benefits which can also influence user satisfaction. The e-government system success model can be built around this updated model. Our model incorporates information quality, system quality, and service quality as in the DeLone and McLean model. However, the 'system use' dimension has been replaced by perceived usefulness, as suggested by Seddon[1998]. In addition, because the e-government systems that this paper focuses on are internal public systems used in government agencies, the 'net benefits' dimension has been replaced by perceived work efficiency. Based on the proposed model, a total of nine hypotheses have been formulated which we tested using an empirical analysis. Methods A questionnaire form has been created with items that are designed to examine the relationships among the variables in the model. The questionnaire has been handed over, in person, to 65 members of Chungwadae staff who are now actively using the E-Support System, the present information system created to support internal work at Chungwadae. We made arrangements to meet with each individual who agreed to participate in our survey, and helped to fill out the survey form with explanations. Of the 65 copies that were delivered, only 33 were returned, and 30 responses of these have been adopted for our analysis, since three were not valid. The extremely small sample size was due to the limited number of staff members who had adequate experience required of this study. Results We gathered data from the questionnaire survey and analyzed them using a regression analysis to test the hypotheses. As shown in the table below, the results indicated that all three dimensions of an information system’s quality are positively related to user satisfaction. However, information quality and system quality were found to be positively related to perceived usefulness, while service quality was not. In addition, perceived usefulness is not positively related to user satisfaction, implying that a user may find a system useful, but may not be satisfied with it. Finally, user satisfaction and perceived usefulness both are positively related to perceived work efficiency. This suggests that workers' positive experience with the system is important to guarantee favorable work efficiency. Conclusions We conclude that the proposed model proved useful in measuring the success of an internal information system used by a government agency. To demonstrate the applicability and usefulness of the model in the paper, we applied the model to the assessment of the present internal system used at Chungwadae in comparison with the preceding system. The results showed that the present system outperforms the preceding one in a statistically significant way. Future research will have to focus on applying the model to Korea's governmental agencies other than Chungwadae and examine whether it proves applicable in different types of governmental organizations.

Clinical Evaluation of Open Thoracotomy Cases in Spontaneous Pneumothorax (자연 기흉의 개흉례에 대한 임상적 고찰)

  • 이연재;황산원
    • Journal of Chest Surgery
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    • v.30 no.12
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    • pp.1225-1231
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    • 1997
  • Spontaneous pneumothorax is the sudden collapse of a lung usually caused by air leakage from a subvisceral pleural blob. Responses to closed thoracostomy,thoracentesls and simple observation are usually prompt and effective. But in some cases, these are unsucceful and open thoracotomy is indicated. A clinical evaluation was performed on 242 cases(236 patients) of open thoracotomy in spontaneous pneumoth rax who were admitted and treated at department of Thoracic and Cardiovascular Surgery. Masan Samsung General Hospital during the past 9 years from January 1988 to December 1996. The results were as follows 1. The sex ratio was male predominance(M:F=11.7:1) 2. The most common age group were 2nd, 3rd decades(2nd=29.3%, 3rd=30.2%). 3. The most common chief complaints were chest pain and dyspnea(chest pain=41.7%. dryspnea= 36.8). 4. The etiologic factors of spontaneous pneumothorax were primary spontaneous pneumothorax(86.4%), tuberculosis(9.1%), COPD(3.7%) and pleuritis(0.8%). 5. The site of spontaneous pneumothorax was 52.1% in right, 45.4% in left and 2.5% in both. 6. The common indications of open thoracotomy were recurrence(44.2%), persistent air leakage(31.8%) and inadequate expansion(15.7%). 7. The operative procedures were bullectomy or mechanical pleurodesis through posterolateral thoracotomy or median sternotomy. 8. The most frequent location of bulla or blob were apical segme t oi RUL(35.1%) and apicoposterior segment of LUL(41.3 %). 9. The number of bulla or blob were mainly 1 to 5(88%), and there were no significant differences among operation indications. 10. The size of bulla or bleb were mainly below 5cm(81%)and small bulla($\leq$1cm) were predominant in recurrence group but large bulla(>5cm)were predominant in persistent air leakage and inadequate expansion group. 11. The pleural adhesion was seen in 54.5%.(Recurrence group 64.1%,Persistent air leakage group 51.9%,Inadequate expansion group 47.4%).

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Development and Performance Test of Preamplifier and Amplifier for Gamma Probe (감마프로브용 전단증폭기와 주증폭기의 개발과 성능 평가)

  • Bong, Jung-Kyun;Kim, Hee-Joung;Lee, Jong-Doo;Kwon, Soo-Il
    • The Korean Journal of Nuclear Medicine
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    • v.33 no.1
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    • pp.100-109
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    • 1999
  • Purpose: Preamplifier and amplifier are very important parts for developing a portable counting or imaging gamma probe. They can be used for analyzing pulses containing energy and position information for the emitted radiations. The commercial Nuclear Instrument Modules (NIMs) can be used for processing these pulses. However, it may be improper to use NIMs in developing a portable gamma probe, because of its size and high price. The purpose of this study was to develop both preamplifier and amplifier and measure their performance characteristics. Materials and Methods: The preamplifier and amplifier were designed as a charge sensitive device and a capacitor resistor-resistor capacitor (CR-RC) electronic circuit, respectively, and they were mounted on a print circuit board (PCB). We acquired and analyzed energy spectra for Tc-99m and Cs-137 using both PCB and NIMs. Multichannel analyzer (Accuspec/A, Canberra Industries Inc., Meriden Connecticut, U.S.A) and scintillation detectors (EP-047(Bicron Saint-Gobain/Norton Industrial EP-047 (Ceramics Co., Ohio, U.S.A) with $2"{\times}2"$ NaI(T1) crystal and R1535 (Hamamatsu Photonics K.K., Electron Tube Center, Shizuoka-ken, Japan) with $1"{\times}1"$ NaI(T1) crystal were used for acquiring the energy spectra. Results: Using PCB, energy resolutions of EP-047 detectors for Tc-99m and Cs-137 were 12.92% and 5.01%, respectively, whereas R1535 showed 13.75% and 5.19% of energy resolution. Using the NIM devices, energy resolutions of EP-047 detector for Tc-99m and Cs-137 were measured as 14.6% and 7.58%, respectively. However, reliable energy spectrum of R1535 detector could not be acquired, since its photomultiplier tube (PMT) requires a specific type of preamplifier. Conclusion: We developed a special preamplifier and amplifier suitable for a small sized gamma probe that showed good energy resolutions independent of PMT types. The results indicate that the PCB can be used in developing both counting and imaging gamma probe.

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Changes of Fruit Structure and Sugar Contents during the Fruit Growth and Development in 'Yumyeong' Peach [Prunus persica (L.) Batsch] (과실생육시기별 '유명' 복숭아의 과실조직 발달과 당 변화)

  • Cho, Myong-Dong;Park, Hee-Seung;Kim, Yong-Koo
    • Horticultural Science & Technology
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    • v.18 no.3
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    • pp.353-359
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    • 2000
  • 'Yumyeong' is one of the most popular peach varieties in Korea. This study was conducted to monitor the developments of cells and tissues, and the changes in sugar contents during fruit growth and development. At bloom, there were two rows of vascular tissues, and the number and the position of internal vascular bundles were consistent during the fruit growth, however, the number of vascular tissues were increased and the distribution was irregular in the flesh tissues. The tissues between the inner integument and the internal vascular bundles showed different development characteristics from other parenchyma cells which were consisted of small and dense cells containing tannins. Such observation suggested that the stone of peach was consisted of inner epidermis and cells in the internal vascular tissues. The outer epidermis consisted of single layer cells at bloom differrentiated into 1-2 layers by horizontal cell divisions on 14 days after full bloom. On 30 days after full bloom, the epidermis was consisted of 5-6 layers by vertical cell divisions. The cell layers consisting the outer epidermis were gradually decreased to 1-2 layers at maturity. The observations on the changes in the epidermis confirmed that some of the cells consisting the hypodermis of peach fruit were originated from the cells of outer epidermis. Tylosis was observed from 35 days after full bloom and the size and number of tylosis were increased until full fruit maturity. The sucrose content showed the tendency of sharp increase from 50 days to 120 days after full bloom then decrease slightly. After when stone hardening ended, other solids showed a gradual decrease tendency from 80 days after full bloom.

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Laval Growth Rate of Nannophya pygmaea(Odonata: Libellulidae), an Endangered Dragonfly in Korea (한국의 멸종위기종인 꼬마잠자리 (Nannophya pygmaea Rambur: 잠자리과, 잠자리목) 유충의 성장률)

  • Kim, Dong-Gun;Yoon, Tae-Joong;Oh, Chi-Gyeong;Kim, Jae-Geun;Lee, Eun-Heui;Bae, Yeon-Jae
    • Korean Journal of Ecology and Environment
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    • v.42 no.3
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    • pp.290-294
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    • 2009
  • Larval development of Nannopaya pygmaea Rambur (Libellulidae), an endangered dragonfly in Korea, was studied using an introduced lariat population in an artificial wetland habitat. Artificial habitat was created in a green house which imitated a small wetland in Boryeong-si, Chungcheongnam-do, Korea, where N. pygmaea inhabited. A total of 300 N. pygmaea larvae were introduced to the artificial habitat in June 2007. Larvae were recaptured five times between June 2007 and November 2008 for measurement of body length. As a result, the initial and recaptured populations (Recaptured I, II, III, IV, and V populations, respectively) contained two body size groups [initial 6.20$\pm$0.34 mm and 7.94$\pm$0.46 mm (mean$\pm$SD); Recaptured I 2.84$\pm$0.43 mm and 5.16$\pm$0.83 mm; Recaptured II 5.96$\pm$0.66 mm and 8.02$\pm$0.35 mm; Recaptured III 5.97$\pm$0.73 mm and 7.82$\pm$0.37 mm; Recaptured IV 7.04$\pm$0.93 mm and 8.52$\pm$0.39 mm; Recaptured V 5.72$\pm$0.60 mm and 7.71$\pm$0.30 mm]. Our rearing experiment evidenced that the recaptured I-V populations are the offspring of the initial population and the offspring grew approximately 3 mm at 470 degree days. It was also estimated that N. pygmaea larvae need approximately 100 degree days to grow 0.7 mm in body length.

The Effects of Maternal HBs antigenemia on the Neonatal Health (산모(産母)의 B형 간염(肝炎) Virus 보유(保有)가 신생아(新生兒) 건강(健康)에 미치는 영향(影響))

  • Park, Jung-Han;Yoon, Sung-Do;Kim, Chang-Youn;Lee, Sung-Kwan
    • Journal of Preventive Medicine and Public Health
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    • v.17 no.1
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    • pp.47-55
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    • 1984
  • To study the risk factors associated with maternal HBsAg carrier and the effects of maternal HBs antigenemia on the neonatal health, sera of 729 pergnant women admitted to the Keimyung University Hospital for delivery during the period of February 1-May 30. 1982 were tested for HBsAg by RPHA method and for anti-HBs by PHA method. Among them 43 women (5.9%) had HBsAg and 246 women (33.7%) had anti-HBs giving an infection rate of 39.6%. The interview data for 43 HBsAg positive mothers and randomly selected 210 HBsAg negative mothers showed a statistically significant association between acupuncture history and HBsAg positive rate (p<0.005) which suggest that acupuncture might have contributed significantly to the propagation of viral hepatitis in Korea. The living standard of HBsAg positive mothers was generally lower than that of HBsAg negative mothers which supports the hypothesis that environmental factors are associated with viral hepatitis B infection. None of the 43 neonates born to HBsAg positive mothers had HBsAg in their cord blood. Three months after birth, 35 out of 43 infants were retested and only one infant became HBsAg positive. At six months of age, 32 out of 35 infants were retested and none of them were HBsAg positive except the same infant who was positive at three months. Among 20 control infants of HBsAg negative mothers, all of them were HBsAg negative at three and six months follow-up. These findings are not consistent with the supposition that perinatal infection is a main route of viral hepatitis B transmission in south-east Asia including Korea. HBsAg positive mothers had significantly higher rate of premature delivery (27.9%) than HBsAg negative mothers (11.7%) (p<0.05). Also, the low birthweight incidence rate was higher among HBsAg positive mothers (23.3%) than negative mothers (14.1%) but this was not statistically significant (P=0.16). The premature rupture of membrane was more frequent among HBsAg positive mothers (25.5%) than negative mothers (11.1%) (p<0.05). There were no significant differences in the stillbirth rate and incidence of congenital anomalies between HBsAg positive and negative groups. It was not clarified in this study due to small sample size whether higher incidence of premature delivery and premature rupture of membranes among HBsAg positive mothers was due to HBs antigenemia per so or their lower living standard than HBsAg negative mothers.

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A Simulation-Based Investigation of an Advanced Traveler Information System with V2V in Urban Network (시뮬레이션기법을 통한 차량 간 통신을 이용한 첨단교통정보시스템의 효과 분석 (도시 도로망을 중심으로))

  • Kim, Hoe-Kyoung
    • Journal of Korean Society of Transportation
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    • v.29 no.5
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    • pp.121-138
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    • 2011
  • More affordable and available cutting-edge technologies (e.g., wireless vehicle communication) are regarded as a possible alternative to the fixed infrastructure-based traffic information system requiring the expensive infrastructure investments and mostly implemented in the uninterrupted freeway network with limited spatial system expansion. This paper develops an advanced decentralized traveler information System (ATIS) using vehicle-to-vehicle (V2V) communication system whose performance (drivers' travel time savings) are enhanced by three complementary functions (autonomous automatic incident detection algorithm, reliable sample size function, and driver behavior model) and evaluates it in the typical $6{\times}6$ urban grid network with non-recurrent traffic state (traffic incident) with the varying key parameters (traffic flow, communication radio range, and penetration ratio), employing the off-the-shelf microscopic simulation model (VISSIM) under the ideal vehicle communication environment. Simulation outputs indicate that as the three key parameters are increased more participating vehicles are involved for traffic data propagation in the less communication groups at the faster data dissemination speed. Also, participating vehicles saved their travel time by dynamically updating the up-to-date traffic states and searching for the new route. Focusing on the travel time difference of (instant) re-routing vehicles, lower traffic flow cases saved more time than higher traffic flow ones. This is because a relatively small number of vehicles in 300vph case re-route during the most system-efficient time period (the early time of the traffic incident) but more vehicles in 514vph case re-route during less system-efficient time period, even after the incident is resolved. Also, normally re-routings on the network-entering links saved more travel time than any other places inside the network except the case where the direct effect of traffic incident triggers vehicle re-routings during the effective incident time period and the location and direction of the incident link determines the spatial distribution of re-routing vehicles.

Hyperfractionation Radiation Therapy in Advanced Head and Neck Cancer (진행된 두경부암에서 다분할 방사선치료)

  • Kim, Jin-Hee;Ye, Ji-Won
    • Radiation Oncology Journal
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    • v.21 no.2
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    • pp.112-117
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    • 2003
  • Purpose: The effects of hypefractionation radiation therapy, such as the failure pattern and survival, on the treatment results in advanced stage head and neck cancer were studied. Materials and Methods: Between September 1990 and October 1998, 24 patients with advanced stage (III, IV) head and neck cancers, were treated using hyperfractionation radiation therapy in the Department of Radiation Oncology at the Keimyung University Dongsan Medical Center. The male to female ratio was 7 : 1, and the age range from 38 to 71 years with the median of 56 years. With regard to the TNM stage, 11 patients were stage III and 13 were stage IV. The sites of primary cancer were the nasopharynx in six, the hypopharynx in 6, the larynx in five, the oropharynx in three, the maxillary sinus in three, and the oral cavity in one patient. The radiotherapy was delivered by 6 MV X-ray, with a fraction size of 1.2 Gy at two fractions a day, with at least 6 hours inter-fractional interval. The mean total radiation doses was 72 Gy, (ranging from 64.4 to 75.8 Gy). Follow-up periods ranged between 3 and 136 months, with the median of 52 months. Results: The overall survival rates at 3 and 5 years in all patients were 66.7$\%$, and 52.4$\%$. The disease-free survival rates at 3 and S years (3YDFS, 5YDFS) in all patients were 66.7$\%$ and 47.6$\%$. The 3YDFS and 5YDFS in stage III patients were 81.8$\%$ and 63.6$\%$, and those in stage IV patients were 53.8$\%$ and 32.3$\%$. Ten patients were alive with no local nor distant failures at the time of analyses. Six patients (25$\%$) died due to distant metastasis and 12.5$\%$ died due to local failure. Distant metastasis was the major cause of failure, but 2 patients died due to unknown failures and 3 of other diseases. The distant metastasis sites were the lung (3 patients), the bone (1 patient), and the liver (2 patients). One patient died of second esophageal cancer. There were no severe late complications, with the exception of 1 osteo-radionecrosis of the mandible 58 months after treatment. Conclusion: Although this study was peformed on small patients group, we considered hypefractionated radiation therapy for the treatment of advanced stage head and neck cancer might improve the disease free survival and decrease the local failure with no increase in late complications despite of the slight Increase in acute complications.