Report of
FNCA 2015 Workshop on Radiation Oncology Project

Outline of Workshop

The FNCA 2015 Workshop on Radiation Oncology was held from 1 to 4 December 2015 in Hanoi, Vietnam.
The workshop was co-organized by National Cancer Hospital (K-Hospital) and Vietnam Atomic Energy Institute (VINATOM) and the Ministry of Education, Culture, Sports, Science and Technology of Japan (MEXT).
33 participants from 11 FNCA Member Countries, namely Bangladesh, China, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mongolia, the Philippines, Thailand and Vietnam participated in the workshop.
This project carries out some international joint clinical studies in order to establish treatment protocols for Uterine Cervix cancer, Nasopharyngeal cancer and Breast cancer, which affect large number of people in FNCA member countries, and finally to improve the technique of radiation oncology in the Asian region.

Opening Ceremony
Dr. To Anh Dung, Vice Head of Breast and Gynecology Radiotherapy Department, K-Hospital moderated the session.
Dr. BUI Dang Hanh, Deputy Director of International Cooperation of VINATOM, gave the opening address.
Prof. BUI Cong Toan, Vice Director of K-Hospital said a few words of welcome.
Also, Dr. Hirohiko Tsujii, Fellow and Former Executive Director of National Institute of Radiological Sciences (NIRS) gave his opening remarks, and he also talked about Dr. Sueo Machi, FNCA Coordinator of Japan, who passed away on August 15 this year. He expressed many thanks for his contribution to FNCA activities and heartfelt condolences.

Dr. Ngo Thanh Tung, Department of Head and Neck Radiotherapy, K-Hospital, gave a special lecture entitled "Status of Chemoradiotherapy for NPC in Vietnam (2005-2015)". He spoke about the current status of NPC in Vietnam including its incidence, the number of patients treated per year and presented the results of treatment of three different regimens such as NPC I, NCCN, and NPC III in their center.

Phase II Study of Concurrent Chemotherapy and Extended-Field Radiotherapy for Locally Advanced Cervical Cancer (CERVIX-IV)
In this protocol, 103 patients were registered from all the countries at the point of this workshop. The 103 cases were consisted of Bangladesh (31), China (7), Indonesia (9), Japan (20), Korea (7), Malaysia (5), Mongolia (8), Philippines (4) Thailand (4) and Viet Nam (8).

91 cases out of the 103 cases were considered evaluable. Of the 91, 48 patients had stage IIB disease and 43 had stage IIIB disease. All patients had positive PLN and negative PALN assessed by CT (or US). Grade 3 leukopenia occurred in 19 (21 %) patients. Grade 3/4 nausea/vomiting occurred in 3 (3 %) patients. These toxicities were manageable. Seventy four (81 %) patients received > 4 cycles of chemotherapy. The 2-year and 5-year LC were 96% and 92%, respectively. The 2-year and 5-year PFS were 77% and 58%, respectively. The 2-year and 5-year OS were 90% and 69%, respectively.

Longer follow-up period is needed to evaluate treatment safety and efficacy.

An open discussion on the clinical data of Cervix-IV followed. The difficulty in determining the status of patients from Indonesia was raised as the evaluation was done through telephone or through the social worker only. On the other hand, cases from Korea used a different chemotherapy schedule. Will these cases be included in the analysis of the study? It was also suggested to perform a sub-analysis based on the following parameters: tumor size, number of pelvic lymph node metastasis, number of chemotherapy cycles completed, use of IGBT, etc.

A New Protocol for Cervical Cancers (Retro CERVIX-V)
Based on the agreement at the last FNCA WS, participants discussed 3D Image Guided Brachytherapy (3D-IGBT) for cervical cancer in FNCA member countries.

First, participants reported the current status of brachytherapy for cervical cancer in their own institutes and discussed the technical feasibility of 3D-IGBT.

CT-based 3D-IGBT is most commonly used in FNCA member countries. 3D treatment planning is performed for all patients and in every brachytherapy session in many participating institutes. Regarding target dose, both point A doses and D90 of high risk clinical target volume (HR-CTV) are most commonly calculated, and the dose is prescribed based on D90 of HR-CTV. Regarding doses to the organs at risk (OARs), both International Commission of Radiation Unit and Measurement (ICRU) rectal and bladder doses and D2cc of the rectum and bladder are most commonly calculated, and the prescribed dose is optimized based on the dose constraints of D2cc of the rectum and bladder. 3D-IGBT is considered technically feasible in most participating institutes, although there are several difficulties, including heavy workload, manpower shortage, and limited time for treatment planning (Refer to Annex Table 1).

Table 1. Status of implementation of 3D-IGBT for cervical cancer in FNCA countries

(Abbreviation; BAN, Bangladesh, CHN, China, IDN, Indonesia, JPN, Japan, KAZ, Kazakhstan, KOR, Korea, MAL, Malaysia, MON, Mongolia, PHL, the Philippines, THA, Thailand, VNM, Viet Nam, BT, brachytherapy, IR-CTV, intermediate risk clinical target volume, CT, computed tomography, MRI, magnet resonance imaging, Xp, x-ray photograph, Fr, fraction, D90, minimum dose delivered to 90% of the volume of interest, D2cc, minimum dose delivered to 2cc of the most irradiated tissue volume)

Next, Japan presented the International Atomic Energy Agency/Regional Cooperative Agreement (IAEA/RCA) project "Supporting 3D-IGBT Services in the RCA Region". The project was conducted from 2012 to 2015. 15 RCA Member States participated in the project, including Australia, Bangladesh, China, India, Indonesia, Japan, Korea, Malaysia, Mongolia, Myanmar, Pakistan, the Philippines, Thailand, Singapore, and Viet Nam. Under the project, 4 Regional Training Courses (RTCs) and several National Training Courses were held to train radiation oncologists and medical physicists in the field of 3D-IGBT. 121 radiation oncologists and medical physicists were trained at the RTCs. A guideline "Transition from 2D Brachytherapy to 3D High Dose Rate Brachytherapy" was developed. The number of institutes which implemented 3D- IGBT have increased in the RCA member states from 12% in 2012 to 20% in 2015.

A retrospective study of 3D-IGBT for cervical cancer (Retro Cervix-V) was proposed by Japan. This retrospective study will be conducted to investigate the method of 3D-IGBT among FNCA member countries. This will include dose volume histogram parameters used for assessment of the doses to the target volume and OARs at brachytherapy, the dose of external beam radiotherapy to the whole pelvis, the planning aim doses of brachytherapy, and actual delivered doses to the target volume and OARs, etc. The goal of the study is to develop a consensus on 3D-IGBT for cervical cancer among FNCA member countries which will serve as the basis for CERVIX-V.

The retrospective study was discussed, and it was agreed to conduct the study. Each participant which implements 3D-IGBT will be requested to submit data of at least 5 patients treated with 3D-IGBT to the data center. The case report form (CRF) will be supplied by the data center.

Phase II Study of Concurrent Chemoradiotherapy (CCRT) for NPC (NPC-III)
A total of 61 patients were registered in this protocol at the time of this workshop. The 61 cases were consisted of Bangladesh (1), China (8), Indonesia (12), Japan (0), Kazakhstan (0), Korea (0), Malaysia (13), Mongolia (0), Philippines (7), Thailand (0) and Vietnam (20). 58 cases out of the 61 cases submitted before the workshop were analyzed and evaluated in this workshop.

Median age was 47 years old. All patients had 2 -3 cycles of neoadjuvant chemotherapy for a compliance rate of 100%, while concurrent chemotherapy showed 76% compliance rate for 4 cycles or more. Median overall treatment time of radiotherapy was 56 days. Treatment was interrupted in 24 patients due to machine breakdown and 8 patients due to toxicities. Grade 3/4 leukopenia occurred in 11% during the induction phase and 20% during the concurrent phase. Grade 3 nausea and vomiting occurred in 9%. Late toxicity of grade 3 xerostomia occurred in 5 patients. Efficacy results: Failure in primary site 7.3%, lymph nodes sites 14.5% and distant sites 18%. Locoregional control rate (LRC) were 85.6% at 2 years and 75.1% at 3 years. Distant metastasis free rate (DMF) was 83.8% at 2 years and remained the same at 3 years. Progression free survival (PFS) was 76.3% at 2 years and 66.7% at 3 years. Overall survival (OS) was 79.7% at 2 years and remained the same at 3 years. When compared with the results from NPC-I study, these results showed better rates in DMF and OS but worse rates in LRC, but all of which were not statistically significant. The target enrolment is 120 patients but only half the number was accrued so far.

Issues discussed:

After discussion about the pros and cons of continuing the study, it was decided to continue with enrolment for 1 more year. Ideas for a new study protocol for NPC should be thought about for next year.

QA/QC of Radiotherapy
This activity aims to put in place reliable dosimetry in the institutes among the member countries for effective joint clinical studies. The audits in QA/QC of dosimetry measurement and radiation calibration have been conducted, which is for the reliable radiotherapy. Report on a review and summary of intercomparison measurements using validated glass dosimeters done on 46 beams (of external beam therapy) in 16 facilities with 4-18 MV at 11 countries in the past 9 years were presented by Japan. The dose audit was performed to facilities participating in the clinical trial of FNCA. Excellent results, 0.4% in average and 1.5% in standard deviation for the dose in reference condition, were obtained. The necessity of the QA audit was re-realized. The manuscript of this summary to be submitted to a scientific journal will be prepared.

Next, "The lessons from incident reports in brachytherapy" was presented by Japan. The recommendations in the reports were as follows: A written comprehensive QA program is essential. Compliance with QA procedures will contribute to minimize the occurrence of errors. While not necessarily required by regulation, a hospital radiation safety committee needs to exist and interact with regulatory and health authorities. Maintenance is an indispensable component of QA. External audits of procedures re-enforces good and safe practice, and identifies potential causes of errors. The objective of all significant steps should be checked and verified to ensure that the correct patient receives the correct dose at the correct site. Peer review of each case improves quality. The feasibility of visiting audit to investigate the performance of QA/QC activity for Brachytherapy, including IGBT is discussed for the future plan of FNCA.

Lastly, Mr. Nguyen Thanh Binh, Medical Physicist, K-Hospital spoke on QA/QC activities of Radiotherapy in K-Hospital and the current situation of Medical Physicist in Viet Nam. He reported that the 1st Conference for Medical Physicists (MP) about the roles and responsibilities of MP in Medicine and Training program was held in Viet Nam. He also reported that the QA/QC activities in K-Hospital has passed the Radiation Safety and Dosimetry Survey of IAEA and VINATOM.

Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (BREAST-I)
A protocol Breast-I was reviewed. A total of 103 patients were registered in this protocol at the point of this workshop. However, the total recent clinical data presented by each country in this session was 102 as follows. Bangladesh (WBI - 19, PMRT- 63), China ( WBI- 6, PMRT - 7 ), Indonesia (WBI- 6; PMRT -0 ), Japan (WBI-59, PMRT - 1 ), Kazakhstan (WBI-10, PMRT-14), Korea (WBI- 2, PMRT -0 ), Malaysia (0 ), Mongolia(WBI-0, PMRT-7) Philippines (WBI-0, PMRT=10 ), Thailand (WBI-7, PMRT-0 ) and Vietnam ( 0 ). Total number of patients was WBI (109) and PMRT (102).

Patients treated with HF-WBI according to stage was as follows: Stage 0-IIB, 0-7, I= 58, IB=2, IIA=30, IIB=13. (Total number 110 because one patient has the cancer lesions in the both breasts) The boost dose was given in 73 patients. The most common risk factor is age. Acute toxicity is mild: skin grade 1= 82%, grade 2 = 13%; subcutaneous grade 1 =13%, grade 2 =1% and very few lung complications. Late effect in skin grade 1 = 28%, subcutaneous grade 1 = 13% and lung grade 2 = 1%. The short term follow-up showed good local control except distant metastases in one, intercurrent death of 1, death from breast cancer is also 1.

The PMRT clinical data of 103 patients was also presented. The staging of patients are as follows: stage IIA =44, IIB=41, IIIA=16, IIIB=1, IIIC=1. The acute toxicity was summarized as: skin toxicity grade 1= 75%, grade 2=1%, grade 3=2%; subcutaneous grade 1=11%, lung grade 1=2%, heart grade 1=1%. Late skin toxicity grade 1 = 28%, subcutaneous grade 1=13%, lung grade 2=1%. The short term follow-up showed loco-regional recurrence = 2, distant metastases = 4, breast cancer death = 2 and no intercurrent death. Overall, trial enrollment has been very active. The short term results, HF RT is assumed to be equally safe and effective compared to conventional method. Long term follow up are needed to confirm the initial results.

An open discussion on the clinical data of Phase II study of Hypofractionated Radiotherapy for Breast Cancer followed. Two points were discussed. First, clarification of grade of skin toxicity. Second, the socioeconomic benefit with assumed equal clinical benefit. Finally, all the participants agreed to continue enrollment of 200 more patients for this protocol.

Future Plan
It was agreed that the next workshop will be held in Indonesia tentatively from November 8 to 11, 2016.
Regarding the proposed study, Retro Cervix-V, each institute will submit 5 cases and their corresponding CRF forms next year.

Closing Session
The workshop was officially closed by Dr. Hirohiko TSUJII's remarks.

Technical Visit
The participants conducted a Technical Visit to Tan Trieu Campus of K-Hospital in the afternoon of the 3rd day. They overserved radiotherapy machines etc. They also visited Quan Su Campus of K- Hospital on the 4th day

Open Seminar
The Open Seminar, as a part of the workshop, was held at Tan Trieu Campus of K- Hospital in the afternoon of the 3rd day. There were 7 lectures on the themes of 1) Introduction of FNCA Radiation Oncology Project (Cervix-Cancer) , 2) Introduction of FNCA Radiation Oncology Project (Breast-Cancer), 3) Present Status of Radiation Oncology in Vietnam,4) Image-guided brachytherapy for cervical cancer, 5) Current status of Radiation treatment in Bangladesh: Need for uniform protocol based treatment for better outcome, 6) Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma - Evolving Evidence and KIRAMS`s Experience 7) Particle Beam Therapy.

Minutes of
FNCA 2015 Workshop on Radiation Oncology Project

(1) Following the agreement at the 16th Forum for Nuclear Cooperation in Asia (FNCA) Coordinators Meeting, the FNCA FY2015 Workshop on Radiation Oncology was held from December 1st to 4th, 2015, in Hanoi, Vietnam. The meeting was co-organized by Vietnam Atomic Energy Institute (VINATOM), National Cancer Hospital (K-Hospital) and the Ministry of Education, Culture, Sports, Science and Technology of Japan (MEXT) Representatives from 11 FNCA member countries, namely Bangladesh, China, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mongolia, the Philippines, Thailand and Vietnam participated in the meeting.

Opening Ceremony
(2) Dr. To Anh Dung, Vice-Head of Breast and Gynecology Radiotherapy Department, K-Hospital moderated the session and he officially opened the workshop.

Dr. BUI Dang Hanh, Deputy Director of International Cooperation of VINATOM, gave the opening address.

Prof. BUI Cong Toan, Vice Director of K-Hospital, said a few words of welcome. He mentioned about the recent rapid increase of cancer patients in Vietnam and emphasized that various treatment measures and modalities are needed to meet the increasing number of cancer patients.

Dr. Hirohiko Tsujii, Fellow and Former Executive Director of National Institute of Radiological Sciences (NIRS) gave his opening remarks, and he also talked about Dr. Sueo Machi, FNCA Coordinator of Japan, who passed away on August 15 this year. He expressed many thanks for his contribution to FNCA activities and heartfelt condolences.

(3) Dr. Ngo Thanh Tung, Department of Head and Neck Radiotherapy, K-Hospital, gave a special lecture entitled "Status of Chemoradiotherapy for NPC in Vietnam (2005-2015)". He spoke about the current status of NPC in Vietnam including its incidence, the number of patients treated per year and presented the results of treatment of three different regimens such as NPC I, NCCN, and NPC III in their center.

(4) Introduction of individual participants followed.

(5) The agenda was adopted and chairpersons and rapporteurs were selected. (Annex 1)

Session 1: Phase II Study of Concurrent Chemotherapy and Extended-Field Radiotherapy for Locally Advanced Cervical Cancer (CERVIX-IV)
(6) Dr. Masaru Wakatsuki, Chief Medical Doctor, Research Center Hospital for Charged Particle Therapy, NIRS, presented the protocol of Cervix IV, a Phase II Study of Concurrent Chemotherapy and Extended-Field Radiotherapy for Locally Advanced Cervical Cancer.

An update on the clinical data of (CERVIX-IV) was presented by representatives of each participating country with the following number of patients: Bangladesh (31), China (7), Indonesia (9), Japan (20), Korea (7), Malaysia (5), Mongolia (8), Philippines (4) Thailand (4) and Viet Nam (8).

Dr. Masaru Wakatsuki then presented the summary of the follow-up data. As of today, Dec. 1, 2015, a total of 103 cases were submitted for this study. Eight (8) new cases were added this year, however, 1 case is not eligible because of the presence of PALN metastasis before the start of treatment. The number of enrolled patients reached the required sample size.

Of the 102 cases that were eligible for this study, 11 cases were not evaluable. Of the 91 evaluable cases 48 patients had stage IIB disease and 43 had stage IIIB disease. All patients had positive PLN and negative PALN assessed by CT (or US). Grade 3 leukopenia occurred in 19 (21 %) patients. Grade 3/4 nausea/vomiting occurred in 3 (3 %) patients. These toxicities were manageable. Seventy four (81 %) patients received > 4 cycles of chemotherapy. The 2-year and 5-year LC were 96% and 92%, respectively. The 2-year and 5-year PFS were 77% and 58%, respectively. The 2-year and 5-year OS were 90% and 69%, respectively.

Longer follow-up period is needed to evaluate treatment safety and efficacy.

(7) An open discussion on the clinical data of Cervix-IV followed. The difficulty in determining the status of patients from Indonesia was raised as the evaluation was done through telephone or through the social worker only. On the other hand, cases from Korea used a different chemotherapy schedule. Will these cases be included in the analysis of the study? It was also suggested to perform a sub-analysis based on the following parameters: tumor size, number of pelvic lymph node metastasis, number of chemotherapy cycles completed, use of IGBT, etc.

Session 2: A New Protocol for Cervical Cancer (Retro CERVIX-V)
(8) Based on the agreement at the last FNCA WS, participants discussed 3D Image Guided Brachytherapy (3D-IGBT) for cervical cancer in FNCA member countries.

(9) First, participants reported the current status of brachytherapy for cervical cancer in their own institutes and discussed the technical feasibility of 3D-IGBT.

CT-based 3D-IGBT is most commonly used in FNCA member countries. 3D treatment planning is performed for all patients and in every brachytherapy session in many participating institutes. Regarding target dose, both point A doses and D90 of high risk clinical target volume (HR-CTV) are most commonly calculated, and the dose is prescribed based on D90 of HR-CTV. Regarding doses to the organs at risk (OARs), both International Commission of Radiation Unit and Measurement (ICRU) rectal and bladder doses and D2cc of the rectum and bladder are most commonly calculated, and the prescribed dose is optimized based on the dose constraints of D2cc of the rectum and bladder. 3D-IGBT is considered technically feasible in most participating institutes, although there are several difficulties, including heavy workload, manpower shortage, and limited time for treatment planning (Refer to Annex Table 1).

Table 1. Status of implementation of 3D-IGBT for cervical cancer in FNCA countries (Abbreviation; BAN, Bangladesh, CHN, China, IDN, Indonesia, JPN, Japan, KAZ, Kazakhstan, KOR, Korea, MAL, Malaysia, MON, Mongolia, PHL, the Philippines, THA, Thailand, VNM, Viet Nam, BT, brachytherapy, IR-CTV, intermediate risk clinical target volume, CT, computed tomography, MRI, magnet resonance imaging, Xp, x-ray photograph, Fr, fraction, D90, minimum dose delivered to 90% of the volume of interest, D2cc, minimum dose delivered to 2cc of the most irradiated tissue volume)

(10) Prof. Shingo Kato, Saitama Medical University, presented the International Atomic Energy Agency/Regional Cooperative Agreement (IAEA/RCA) project "Supporting 3D-IGBT Services in the RCA Region". The project was conducted from 2012 to 2015. 15 RCA Member States participated in the project, including Australia, Bangladesh, China, India, Indonesia, Japan, Korea, Malaysia, Mongolia, Myanmar, Pakistan, the Philippines, Thailand, Singapore, and Viet Nam. Under the project, 4 Regional Training Courses (RTCs) and several National Training Courses were held to train radiation oncologists and medical physicists in the field of 3D-IGBT. 121 radiation oncologists and medical physicists were trained at the RTCs. A guideline "Transition from 2D Brachytherapy to 3D High Dose Rate Brachytherapy" was developed. The number of institutes which implemented 3D- IGBT have increased in the RCA member states from 12% in 2012 to 20% in 2015.

(11) Dr. Masaru Wakatsuki proposed a retrospective study of 3D-IGBT for cervical cancer (Retro Cervix-V). This retrospective study will be conducted to investigate the method of 3D-IGBT among FNCA member countries. This will include dose volume histogram parameters used for assessment of the doses to the target volume and OARs at brachytherapy, the dose of external beam radiotherapy to the whole pelvis, the planning aim doses of brachytherapy, and actual delivered doses to the target volume and OARs, etc. The goal of the study is to develop a consensus on 3D-IGBT for cervical cancer among FNCA member countries which will serve as the basis for CERVIX-V.

(12) The retrospective study was discussed, and it was agreed to conduct the study. Each participant which implements 3D-IGBT will be requested to submit data of at least 5 patients treated with 3D-IGBT to the data center. The case report form (CRF) will be supplied by the data center.

Session 3: Phase II Study of Concurrent Chemoradiotherapy (CCRT) for NPC (NPC-III)
(13) Dr. Hirokazu Makishima, Radiation Oncologist, Research Center Hospital for Charged Particle Therapy, NIRS, introduced the protocol of NPC-III, a Phase II Study of CCRT for NPC. Recent clinical data was presented by representatives of each participating countries.

An update on the clinical data of NPC-III was presented by representatives of each participating country with the following number of patients: Bangladesh ( 1 ), China ( 8 ), Indonesia (12 ), Japan ( 0 ), Kazakhstan ( 0 ), Korea ( 0 ), Malaysia ( 13 ), Mongolia ( 0 ), Philippines ( 7 ) Thailand ( 0 ) and Viet Nam ( 20 ).

Prof. Tatsuya Ohno, Professor, Medical Director, Heavy Ion Medical Center, Gunma University then presented the summary of the follow-up data. A total of 61 patients were registered but 58 were evaluated. Median age was 47 years old. All patients had 2 -3 cycles of neoadjuvant chemotherapy for a compliance rate of 100%, while concurrent chemotherapy showed 76% compliance rate for 4 cycles or more. Median overall treatment time of radiotherapy was 56 days. Treatment was interrupted in 24 patients due to machine breakdown and 8 patients due to toxicities. Grade 3/4 leukopenia occurred in 11% during the induction phase and 20% during the concurrent phase. Grade 3 nausea and vomiting occurred in 9%. Late toxicity of grade 3 xerostomia occurred in 5 patients. Efficacy results: Failure in primary site 7.3%, lymph nodes sites 14.5% and distant sites 18%. Locoregional control rate (LRC) were 85.6% at 2 years and 75.1% at 3 years. Distant metastasis free rate (DMF) was 83.8% at 2 years and remained the same at 3 years. Progression free survival (PFS) was 76.3% at 2 years and 66.7% at 3 years. Overall survival (OS) was 79.7% at 2 years and remained the same at 3 years. When compared with the results from NPC-I study, these results showed better rates in DMF and OS but worse rates in LRC, but all of which were not statistically significant. The target enrolment is 120 patients but only half the number was accrued so far.

Issues discussed :

After discussion about the pros and cons of continuing the study, it was decided to continue with enrolment for 1 more year. Ideas for a new study protocol for NPC should be thought about for next year.

Session 4: QA/QC of Radiotherapy
(14) Report on a review and summary of intercomparison measurements using validated glass dosimeters done on 46 beams in 16 facilities with 4-18 MV at 11 countries in the past 9 years were presented by Dr. Hideyuki Mizuno, Senior Researcher, Research Center for Charged Particle Therapy, NIRS. The dose audit was performed to facilities participating in the clinical trial of FNCA. Excellent results, 0.4% in average and 1.5% in S.D. for the dose in reference condition, were obtained. The necessity of the QA audit was re-realized. Dr. Hideyuki Mizuno will prepare the manuscript of this summary to be submitted to a scientific journal.

(15) On behalf of Dr. Shigekazu Fukuda, Head of Section, Technical Management Section, Department of Accelerator and Medical Physics, Research Center for Charged Particle Therapy, NIRS, Dr. Hideyuki Mizuno presented the lessons from incident reports in brachytherapy. The recommendations were as follows: A written comprehensive QA program is essential. Compliance with QA procedures will contribute to minimize the occurrence of errors. While not necessarily required by regulation, a hospital radiation safety committee needs to exist and interact with regulatory and health authorities. Maintenance is an indispensable component of QA. External audits of procedures re-enforces good and safe practice, and identifies potential causes of errors. The objective of all significant steps should be checked and verified to ensure that the correct patient receives the correct dose at the correct site. Peer review of each case improves quality. The feasibility of visiting audit to investigate the performance of QA/QC activity for Brachytherapy, including IGBT is discussed for the future plan of FNCA.

(16) Mr. Nguyen Thanh Binh, Medical Physicist, K-Hospital spoke on QA/QC activities of Radiotherapy in K-Hospital and the current situation of Medical Physicist in Viet Nam. He reported that the 1st Conference for Medical Physicists (MP) about the roles and responsibilities of MP in Medicine and Training program was held in Viet Nam. He also reported that the QA/QC activities in K-Hospital has passed the Radiation Safety and Dosimetry Survey of IAEA and VINATOM.

Session 5 : Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (BREAST-I)
(17) Prof. Kumiko Karasawa, Professor and Chair, Department of Radiation Oncology, School of Medicine, Tokyo Women's Medical University introduced and reviewed the protocol of BREAST-I.

The clinical data of Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (BREAST-I) was presented by representatives of each participating countries. The following numbers were reported: Bangladesh (WBI -19, PMRT- 63), China (WBI- 6, PMRT- 7), Indonesia (WBI- 6, PMRT- 0), Japan (WBI- 59, PMRT- 1), Kazakhstan (WBI- 10, PMRT- 14), Korea (WBI- 2, PMRT - 0), Malaysia (WBI- 0, PMRT- 0), Mongolia (WBI- 0, PMRT- 7), Philippines (WBI- 0, PMRT- 10), Thailand (WBI- 7, PMRT- 0) and Vietnam (WBI- 0, PMRT-0 ). Total number of patients was WBI (109) and PMRT (103).

(18) Prof. Kumiko Karasawa presented the summary of the WBI clinical data of 109 breast cancer cases (110 breasts). The staging of patients are as follows: Stage 0=7, I= 58, IB=2, IIA=30, IIB=13. The boost dose was given in 73 patients. The most common risk factor is age. Acute toxicity is mild: skin grade 1= 82%, grade 2 = 13%; subcutaneous grade 1 =13%, grade 2 =1% and very few lung complications. Late effect in skin grade 1 = 28%, subcutaneous grade 1 = 13% and lung grade 2 = 1%. The short term follow-up showed good local control except distant metastases in one, intercurrent death of 1, death from breast cancer is also 1.

The PMRT clinical data of 103 patients was also presented. The staging of patients are as follows: stage IIA =44, IIB=41, IIIA=16, IIIB=1, IIIC=1. The acute toxicity was summarized as: skin toxicity grade 1= 75%, grade 2=1%, grade 3=2%; subcutaneous grade 1=11%, lung grade 1=2%, heart grade 1=1%. Late skin toxicity grade 1 = 28%, subcutaneous grade 1=13%, lung grade 2=1%. The short term follow-up showed loco-regional recurrence = 2, distant metastases = 4, breast cancer death = 2 and no intercurrent death. Overall, trial enrollment has been very active. The short term results, HF RT is assumed to be equally safe and effective compared to conventional method. Long term follow up are needed to confirm the initial results.

(19) An open discussion on the clinical data of Phase II study of Hypofractionated Radiotherapy for Breast Cancer followed. Two points were discussed. First, clarification of grade of skin toxicity. Second, the socioeconomic benefit with assumed equal clinical benefit. Finally, we all agree to continue enrollment of 200 more patients for this protocol.

Session 6: Future Plan
Regarding next Workshop and other activities, the following items were discussed and agreed upon.

Session 7: Drafting the Workshop Minutes
(20) The draft of the minutes was submitted by rapporteurs, discussed and then amended. The draft of the minutes was unanimously adopted by the workshop participants.

Session 8 Closing Ceremony
(21) Dr. Hirohiko Tsujii gave his closing remarks. The workshop was officially closed.

Session 9: Technical Visit at Tan Trieu Campus, K- Hospital
(22) The participants conducted a Technical Visit to Tan Trieu Campus, K-Hospital.

Session 10: Open Seminar
(23) The Open Seminar was held at Tan True Campus as part of the workshop. Dr. To Anh Dung, K-Hospital gave his remarks. Seven interesting and innovative topics were presented by distinguished speakers. Dr. Chul Koo Cho and Dr. Hirohiko Tsujii moderated the session.

(24) Prof. Shingo Kato gave a lecture on Introduction of FNCA Oncology Project and FNCA protocols for Cervical Cancer.

(25) Prof. Kumiko Karasawa gave a lecture on Introduction of FNCA Oncology Project and FNCA protocols for Breast Cancer.

(26) Dr.Nguyen Cong Hoang, Vice-Head of General Radiotherapy Department, National Cancer Hospital spoke on Present Status of Radiation Oncology in Vietnam.

(27) Prof. Tatsuya Ohno gave a lecture on Image-Guided Brachytherapy for Cervical Cancer.

(28) Dr. A.F.M Kamal Uddin, Lecturer of Dhaka Dental College gave a lecture entitled Current Status of Radiation Treatment in Bangladesh: Need for uniform protocol based treatment for better outcome.

(29) Dr. Won Il Jang, Chief, Department of Radiation Oncology, Korea Institute of Radiological & Medical Sciences (KIRAMS), gave a lecture on Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Evolving Evidence and KIRAMS's Experience.

(30) The last lecture was delivered by Prof. Takashi Nakano, Professor, Gunma University Graduate School of Medicine. He gave a lecture on Particle Beam Therapy.

(31) Dr. Hirohiko Tsujii concluded the Open Seminar with his closing remarks.

Session 11 Technical Visit at Quan Su Campus, K-Hospital.
(32) Another technical visit was also conducted at Quan Su Campus, National Cancer Hospital.

Agenda of
FNCA 2015 Workshop on Radiation Oncology Project

Day 1 Tue, 1st December 2015
Place : Sunway Hotel Hanoi

Day 2 Wed, 2nd December 2015
Place : Sunway Hotel Hanoi

Day 3 Thu, 3rd December 2015
Place : Sunway Hotel Hanoi

Day 4 Fri, 4th December 2015
Place : Quan Su Campus, National Cancer Hospital (K Hospital)

List of Participants
FNCA 2015 Workshop on Radiation Oncology Project

Bangladesh

China

Indonesia

Japan

Kazakhstan

Korea

Malaysia

Mongolia

The Philippines

Thailand

Viet Nam