Report of
FNCA FY2018 Workshop on Radiation Oncology

Outline of Workshop

The FNCA 2018 Workshop on Radiation Oncology was held from 4 to 7 November, 2018 in Dhaka, Bangladesh. The workshop was co-organized by Bangladesh Atomic Energy Commission (BAEC), Oncology Club and the Ministry of Education, Culture, Sports, Science and Technology of Japan (MEXT). Representatives from 10 FNCA member countries, namely Bangladesh, China, Indonesia, Japan, Kazakhstan, 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. Zeenat Jabin,Associate Professor & Principal Scientific Officer, National Institute of Nuclear Medicine & Allied Sciences (NINMAS) moderated the session.
Prof. Dr. Md. Sanowar Hossain, Member (Bio-Science), BAEC welcomed the participants with his remarks.
Mr. Tomoaki WADA, FNCA Coordinator of Japan gave the opening address.
Dr. Hideki NAMBA, FNCA Advisor of Japan gave his remarks
Prof. Shingo KATO, the Project Leader of Radiation Oncology Project gave his remarks and introduced the project.
Prof. Dr. Nayuum Chowdhury, Chairman of Bangladesh Atomic Energy Regulatory Authority (BAERA) gave his remarks.
Mr. Mahbubul Hoq, Chairman, BAEC and FNCA Coordinator of Bangladesh delivered an address.
Lastly,Honorable Minister Mr. Yeafesh OSMAN, Ministry of Science and Technology, Bangladesh (MOST) delivered an address as the chief guest. He officially opened the workshop.

Phase II Study of Concurrent Chemoradiotherapy with Extended-Field Radiotherapy for Locally Advanced Cervical Cancer (CERVIX-IV)
In this protocol, 106 patients were registered from all the countries at the point of this workshop. The 106 cases were consisted of Bangladesh (32), China (8), Indonesia (9), Japan (20), Kazakhstan (1), Korea (7), Malaysia (5), Mongolia (8), Philippines (4), Thailand (4) and Vietnam (8).

11 cases (out of 106 cases) were not evaluable.

Of the 95 evaluable cases, 51 patients had stage IIB disease and 44 had stage IIIB disease. All patients had positive pelvic lymph node (PLN) and negative paraaortic lymph node (PALN) assessed by CT or USN. Median overall treatment time was 57 days. Mean dose to point A was 81.9 Gy. Seventy-six (80 %) patients received > 4 cycles of chemotherapy. Grade 3 leukopenia occurred in 19 patients (20%), 1 patient developed grade 4 neutropenia. For late toxicity, sigmoid/rectum grade 3 toxicity was observed in 2 patients, small bowel grade 3 toxicity was observed in 2 patients. The 2-year follow-up rate was 97%. The 2-year and 5-year local control (LC) rates were 96% and 91%, respectively. The 2-year and 5-year progression free survival (PFS) rates were 77% and 69%, respectively. The 2-year and 5-year overall survival (OS) rates were 90% and 77%, respectively.

Discussion on the clinical data of Cervix-IV followed. The result of Cervix-IV is better than Cervix-III, with decreased rate of distant metastases. On the other hand, patients need CT during follow-up. Preliminary analysis showed no difference in OS between stage IIB and IIIB. Patients with negative para-aortic lymph nodes benefited from prophylactic para-aortic lymph node irradiation without increasing toxicity. There is one case of recurrence in the para-aortic nodes which was reviewed in the workshop and was agreed to be not a recurrence. The progression free survival was re-analyzed as 2-year and 5-year PFS rates were 78% and 70%, respectively.

It was announced that a paper on Cervix-IV will be submitted to an international journal.

Prospective Observational Study of 3D-Image guided brachy therapy for Locally Advanced Cervical Cancer (CERVIX-V)
This is a new protocol following Cervix-IV, which is the successful protocol for cervical cancers.
Newly registered clinical data of CERVIX-V was presented by representatives of each participating country with the following number of patients: Bangladesh (0), China (3), Indonesia (6), Japan (2), Kazakhstan (1), Korea (0), Malaysia (1), Mongolia (0), Philippines (4), Thailand (0) and Vietnam (0). The total number of the patients was 17.

Discussion on CERVIX-V followed. Countries with IRB approval started enrolment of patients last year. Some centers are still awaiting for ethics approval such as Bangladesh.

Several issues were raised by different centers.

1. Determination of the correct stage in which the data center can help out by reviewing MRI images.
2. HR-CTV D90 dose should be kept consistent in all fractions or may be increased adaptively when the HR-CTV volume gets smaller, as long as, the OAR constraints are met.
3. There are variations in the IGBT contouring as reflected in HR-CTV volume changes which is due to different contouring skills and experience. As a suggestion, internal examination findings, ultrasound and MRI can be utilized for proper delineation of HR-CTV.
4. Low number of concurrent chemotherapy cycles received by patients. This can be addressed by proper hydration of patients receiving platinum based chemotherapy and better collaboration with gyne-oncologist.
5. Some centers are using IMRT, however dose specification is not covered in the protocol which needs further discussion.
6. A new FIGO staging 2018 was recently published. However, it was agreed that Cervix-V protocol will still use the 2008 FIGO staging.
7. For every fraction of IGBT, it was advised that new CT images should be acquired for proper optimization.

Follow-up should be done by radiation oncologists apart from gyne-oncologists.

QA/QC for 3D-IGBT
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.
Along with the initiation of CERVIX-V, this QA/QC activity also focuses on the brachytherapy.

The report of feasibility studies and audit of 3D-IGBT were presented by Japan. A phantom jig for auditing the 3D-IGBT technique adopted in Cervix-V protocol was developed. Several measurements have been performed as a feasibility study to initiate audits. End-to-end test will be performed by on-site audit. The audit will be initiated after the Monte Carlo simulation has been completed successfully.

The current status of 3D-IGBT in Bangladesh was presented by Bangladesh. It was explained that the transition process from 2D technique to 3D-IGBT. The HDR facilities are available in her country to start 3D-IGBT but more training is needed to improve skills and technique.

A Thai medical physicist, made a presentation on Promotion of 3D-IGBT in Thailand. Radiotherapy and 3D-IGBT facilities in Thailand were introduced. He explained that 3D-IGBT training courses and quality management program to improve efficacy of treatment.

Phase II Study of Neoadjuvant Chemotherapy with Concurrent Chemoradiotherapy (CCRT) for Nasopharyngeal Carcinoma (NPC-III)
A total 113 patients have been registered in this protocol at the time of this workshop. Out of 108 cases, 43 cases were newly registered this year. The 65 cases were consisted of Bangladesh (1), China (9), Indonesia (12), Japan (0), Kazakhstan (0), Korea (0), Malaysia (29), Mongolia (0), Philippines (7) Thailand (0) and Vietnam (55). New cases: 43.

Median follow up was 19.5 months (3-89). Median age was 46 years. All patients had 2 -3 cycles of neoadjuvant chemotherapy for a compliance rate of 100%, while concurrent chemotherapy had 75% compliance rate for 4 cycles or more. Median overall treatment time of radiotherapy was 52 days (range 44 - 232 days). Radiotherapy treatment interruption of >14 days occurred in 23% of patients mainly due to machine breakdown, re-planning and toxicities. For acute hematological toxicities, grade 3/4 toxicities occurred in 14% during the neoadjuvant phase and 28% during the concurrent phase. No patients developed grade 4 or higher acute non-hematological toxicities. The most common grade 3 acute non-hematological toxicities were nausea/vomiting (5%) during the neoadjuvant chemotherapy and mucositis (20%) during the concurrent phase. Grade 4 late toxicities occurred in 13% of patients, mainly salivary gland and subcutaneous tissue toxicities.

Efficacy results showed 3-year survival results: OS rate was 72%. Loco-regional failure rate was 20%. Distant metastasis free survival rate (DMFS) was 77%. PFS rate was 70%. When compared with the results from NPC-I study, a better trend of OS and DMFS was seen in NPC-III although there were no significant differences.

The target enrolment is 120 patients and 113 were accrued so far. As the target number is nearly achieved, it was decided to close patient enrolment at the end of December 2018. However, further follow-up is required to confirm the 3-year clinical outcomes

Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (Postmastectomy Radiation Therapy (PMRT)/BREAST-I)
In this session, a protocol PMRT/BREAST-I was reviewed and the following numbers were reported. Bangladesh (77), China (13), Indonesia (2), Japan (13), Kazakhstan (20), Korea (0), Malaysia (0), Mongolia (26), Philippines (10), Thailand (0) and Vietnam (0).The total number of PMRT patients were 159.

Overall 178 patients in HF-PMRT arm were enrolled during 58 months. Evaluable number of patients was 159. Only 6 patients were newly registered in this year. All patients completed protocol of treatment. The median age was 49 years old (range, 24-80). Eighty patients (50%) had left-sided breast cancer. The clinical stage was IIA in 56 patients (35%), IIB in 62 (39%), IIIA in 36 (23%), IIIB in 3 (2%), and IIIC in 2 (1%), respectively. The median treatment duration was 21 days (range, 21-84). Six patients experienced treatment interruption. Acute dermatitis of grade 2 or higher was observed in 3 patients (1%) and grade 1 acute subcutaneous toxicity was observed in 16 patients (10%). Acute grade 1 cardiac toxicity was observed in 2 patients (2%) and late grade 1 cardiac toxicity in 3 patients (2%). Late grade 1 lung toxicity was observed in 10 patients (6%). Four loco-regional recurrence, 16 distant metastases and 8 breast cancer deaths had been observed.

An open discussion on the clinical data followed. Only one percent of more than grade 2 acute dermatitis and one percent grade 2 subcutaneous acute toxicity have been observed. All co-investigators are advised to re-check their data and send corrected data. Co-investigators must evaluate cosmetic outcome at 3 years and 5 years after the treatment and they are encouraged to enroll patients until next year.

Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (Whole Breast Irradiation / BREAST-I)
In this session, a protocol WBI/BREAST-I was reviewed and the following numbers were reported. Bangladesh (31), China (6), Indonesia (16), Japan (137), Kazakhstan (14), Korea (9), Malaysia (0), Mongolia (3), Philippines (0), Thailand (14) and Vietnam (0). Total number of WBI patients was 230. (230 patients / 231 breast lesions).

Overall 231 breast lesions in HF-WBI arm were enrolled from February 2013 to October 2017. The median age of patients are 49 years. The majority of patients are in T1 (60%) N0 (86%), clinical IA (53%). Most histology is IDC (3%) and luminal B category (60%). The treatments of most patients were consistent with the protocol by using 6 MV and field in field technique. Most patients experienced no acute side effect except skin reaction (grade 2: 10%, grade 3: 2%). There were very few late adverse effects (subcutaneous effect grade 1: 10%). There was one locoregional recurrence, 3 distant metastases, 2 breast cancer deaths and 2 intercurrent deaths. In summary, all of the patients completed treatment protocol with good tumor control and very few adverse effects.

An open discussion on the clinical data followed.

Some data correction will be needed before manuscript submission. This report will include early results within 2-year follow-up. Long term follow-up is still needed to confirm the final results. We are expected to follow the patients every six months for 5 years and yearly thereafter.

Future Plan
Japan proposed the project activities of the next year and it was agreed by all of the FNCA member states, as follows:

QA/QC for 3D-IGBT: audit of 3D-IGBT will start next year.

Proposal of other activities. Training of delineation of CTV/OARs.

The next workshop is tentatively scheduled to be held in Suzhou, China from November 11th to 17th, 2019.

Technical Visit at Delta Hospital and United Hospital
On the 3rd day, the WS participants conducted a Technical Visit to Delta Hospital Ltd and United Hospital Ltd.

Hands on Training at United Hospital
Some WS participants participated in a Hands on Training as trainers. They gave the training to local radiation oncologists and medical physicists.

Open Lecture
On the 4th day, the Open Lecture was held at National Institute of Cancer research and Hospital (NICRH).
There were 5 lectures on the themes of 1) Overview and Introduction of FNCA, 2) Current Status of Radiation Oncology in Bangladesh, 3) 3D-IGBT for Cervical Cancers, 4) Past, Present, Future of Radiation Therapy in the Philippines and 5) Particle Beam Therapy..
Prof. Shingo KATO made his comments and Prof. Md Moarraf Hossen concluded the Open Lecture with his closing remarks.

Drafting the Workshop Minutes
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.

Minutes of
FNCA 2018 Workshop on Radiation Oncology Project

(1) Following the agreement at the 19th Forum for Nuclear Cooperation in Asia (FNCA) Coordinators Meeting, the FNCA FY2018 Workshop on Radiation Oncology was held from November 4th to 7th, 2018, in Dhaka, Bangladesh. The meeting was co-organized by Bangladesh Atomic Energy Commission (BAEC), Oncology Club, Bangladesh and the Ministry of Education, Culture, Sports, Science and Technology of Japan (MEXT). Representatives from 10 FNCA member countries, namely Bangladesh, China, Indonesia, Japan, Kazakhstan, Malaysia, Mongolia, the Philippines, Thailand and Vietnam participated in the workshop.

Opening Ceremony
(2) Dr. Zeenat Jabin, Associate Professor & Principal Scientific Officer, National Institute of Nuclear Medicine & Allied Sciences (NINMAS) moderated the session.

Prof. Dr. Md. Sanowar Hossain, Member (Bio-Science) , BAEC welcomed the participants with his remarks.

Mr. Tomoaki WADA, FNCA Coordinator of Japan gave the opening address.

Dr. Hideki NAMBA, FNCA Advisor of Japan gave his remarks

Prof. Shingo KATO, the Project Leader of Radiation Oncology Project gave his remarks and introduced the project.

Prof. Dr. Nayuum Chowdhury, Chairman of Bangladesh Atomic Energy Regulatory Authority (BAERA) gave his remarks.

Mr. Mahbubul Hoq, Chairman, BAEC and FNCA Coordinator of Bangladesh delivered an address.

Honorable Minister Mr. Yeafesh OSMAN, Ministry of Science and Technology, Bangladesh (MOST) delivered an address as the chief guest. He officially opened the workshop.

(3) Introduction of individual participants followed.

(4) The agenda was adopted and chairpersons and rapporteurs were selected.

Session 1: Phase II Study of Concurrent Chemoradiotherapy with Extended-Field Radiotherapy for Locally Advanced Cervical Cancer (CERVIX-IV)
(5) Dr. Noriyuki Okonogi, Section Chief, Gynecologic Tumor, National Institute of Radiological Science (NIRS) Hospital, National Institutes for Quantum and Radiological Science and Technology, Japan (QST), presented the protocol of Cervix IV, a Phase II Study of Concurrent Chemoradiotherapy with 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 (32), China (8), Indonesia (9), Japan (20), Kazakhstan (1), Korea (7), Malaysia (5), Mongolia (8), Philippines (4), Thailand (4) and Vietnam (8). The total number of the patients was 106.

Dr. Okonogi then presented the summary of the follow-up data. As of today, a total of 106 cases were submitted for this study, 11 cases were not evaluable.

Of the 95 evaluable cases, 51 patients had stage IIB disease and 44 had stage IIIB disease. All patients had positive pelvic lymph node (PLN) and negative paraaortic lymph node (PALN) assessed by CT or USN. Median overall treatment time was 57 days. Mean dose to point A was 81.9 Gy. Seventy-six (80 %) patients received > 4 cycles of chemotherapy. Grade 3 leukopenia occurred in 19 patients (20%), 1 patient developed grade 4 neutropenia. For late toxicity, sigmoid/rectum grade 3 toxicity was observed in 2 patients, small bowel grade 3 toxicity was observed in 2 patients. The 2-year follow-up rate was 97%. The 2-year and 5-year local control (LC) rates were 96% and 91%, respectively. The 2-year and 5-year progression free survival (PFS) rates were 77% and 69%, respectively. The 2-year and 5-year overall survival (OS) rates were 90% and 77%, respectively.

(6) An open discussion on the clinical data of Cervix-IV followed. The result of Cervix-IV is better than Cervix-III, with decreased rate of distant metastases. On the other hand, patients need CT during follow-up. Preliminary analysis showed no difference in OS between stage IIB and IIIB. Patients with negative para-aortic lymph nodes benefited from prophylactic para-aortic lymph node irradiation without increasing toxicity. There is one case of recurrence in the para-aortic nodes which was reviewed in the workshop and was agreed to be not a recurrence. The progression free survival was re-analyzed as 2-year and 5-year PFS rates were 78% and 70%, respectively.

(7) It was announced that Prof. Masaru Wakatsuki, Professor, Department of Radiology, Jichi Medical University will submit a paper on Cervix-IV to an international journal.

Session 2: Prospective Observational Study of 3D-Image guided brachy therapy for Locally Advanced Cervical Cancer (CERVIX-V)
(8) Dr. Noriyuki OKONOGI presented the protocol of Cervix-V.

(9) Newly registered clinical data of CERVIX-V was presented by representatives of each participating country with the following number of patients: Bangladesh (0), China (3), Indonesia (6), Japan (2), Kazakhstan (1), Korea (0), Malaysia (1), Mongolia (0), Philippines (4), Thailand (0) and Vietnam (0). The total number of the patients was 17.

(10) Discussion on CERVIX-V followed. Countries with IRB approval started enrolment of patients last year. Some centers are still awaiting for ethics approval such as Bangladesh.

(11) Several issues were raised by different centers.

1. Determination of the correct stage in which the data center can help out by reviewing MRI images.
2. HR-CTV D90 dose should be kept consistent in all fractions or may be increased adaptively when the HR-CTV volume gets smaller, as long as, the OAR constraints are met.
3. There are variations in the IGBT contouring as reflected in HR-CTV volume changes which is due to different contouring skills and experience. As a suggestion, internal examination findings, ultrasound and MRI can be utilized for proper delineation of HR-CTV.
4. Low number of concurrent chemotherapy cycles received by patients. This can be addressed by proper hydration of patients receiving platinum based chemotherapy and better collaboration with gyne-oncologist.
5. Some centers are using IMRT, however dose specification is not covered in the protocol which needs further discussion.
6. A new FIGO staging 2018 was recently published. However, it was agreed that Cervix-V protocol will still use the 2008 FIGO staging.
7. For every fraction of IGBT, it was advised that new CT images should be acquired for proper optimization.
8. Follow-up should be done by radiation oncologists apart from gyne-oncologists.

Session 3: QA/QC for 3D-IGBT
(12) Dr. Hideyuki MIZUNO, Senior Researcher, Department of Radiation Measurement and Dose Assessment, NIRS, QST, reported on feasibility studies and audit of 3D-IGBT. A phantom jig for auditing the 3D-IGBT technique adopted in Cervix-V protocol was developed. Several measurements have been performed as a feasibility study to initiate audits. End-to-end test will be performed by on-site audit. The audit will be initiated after the Monte Carlo simulation has been completed successfully.

(13) Mrs. Mushfika Ahmed, Senior Medical Physicist, Delta Hospital Ltd presented the current status of 3D-IGBT in Bangladesh. She explained the transition process from 2D technique to 3D-IGBT. The HDR facilities are available in her country to start 3D-IGBT but more training is needed to improve skills and technique.

(14) Mr. Pitchayut Nakkrasae, Medical Physicist, Faculty of Medicine, Siriraj Hospital made a presentation on Promotion of 3D-IGBT in Thailand. He introduced radiotherapy and 3D-IGBT facilities in Thailand. Also, he explained 3D-IGBT training courses and quality management program to improve efficacy of treatment.

Session 4: Phase II Study of Neoadjuvant Chemotherapy with Concurrent Chemoradiotherapy (CCRT) for Nasopharyngeal Carcinoma (NPC-III)
(15) Prof. Tatsuya OHNO, Professor/Medical Director of Heavy Ion Medical Center, Gunma University introduced the protocol of NPC-III, a Phase II Study of Neoadjuvant Chemotherapy with CCRT for Nasopharyngeal Carcinoma (NPC). Recent clinical data was presented by representatives of each participating country.

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 ( 9 ), Indonesia ( 12 ), Japan ( 0 ), Kazakhstan ( 0 ), Korea ( 0 ), Malaysia ( 29 ), Mongolia ( 0 ), Philippines ( 7 ) Thailand ( 0 ) and Vietnam ( 55 ). The total number of the patients was 113. New cases: 43.

(16) Prof. OHNO then presented the summary of the follow-up data.

Median follow up was 19.5 months (3-89). Median age was 46 years. All patients had 2 -3 cycles of neoadjuvant chemotherapy for a compliance rate of 100%, while concurrent chemotherapy had 75% compliance rate for 4 cycles or more. Median overall treatment time of radiotherapy was 52 days (range 44 - 232 days). Radiotherapy treatment interruption of >14 days occurred in 23% of patients mainly due to machine breakdown, re-planning and toxicities. For acute hematological toxicities, grade 3/4 toxicities occurred in 14% during the neoadjuvant phase and 28% during the concurrent phase. No patients developed grade 4 or higher acute non-hematological toxicities. The most common grade 3 acute non-hematological toxicities were nausea/vomiting (5%) during the neoadjuvant chemotherapy and mucositis (20%) during the concurrent phase. Grade 4 late toxicities occurred in 13% of patients, mainly salivary gland and subcutaneous tissue toxicities.

(17) Efficacy results showed 3-year survival results: OS rate was 72%. Loco-regional failure rate was 20%. Distant metastasis free survival rate (DMFS) was 77%. PFS rate was 70%. When compared with the results from NPC-I study, a better trend of OS and DMFS was seen in NPC-III although there were no significant differences.

The target enrolment is 120 patients and 113 were accrued so far. As the target number is nearly achieved, it was decided to close patient enrolment at the end of December 2018. However, further follow-up is required to confirm the 3-year clinical outcomes.

Session 5: Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (Postmastectomy Radiation Therapy (PMRT)/BREAST-I)
(18) Dr. Sawa KONO, Assistant Professor, Department of Radiation Oncology, Tokyo Women's Medical University introduced and reviewed the protocol of PMRT/BREAST-I.

(19) The clinical data of Phase II Study of Postmastectomy Radiation Therapy (PMRT) was presented by representatives of each participating countries. The following number of patients were reported: Bangladesh (77), China (13), Indonesia (0), Japan (13), Kazakhstan (20), Korea (0), Malaysia (0), Mongolia (26), Philippines (10), Thailand (0) and Vietnam (0). The total number of PMRT patients were 159.

(20) Prof. Kumiko KARASAWA, Dean of School of Medicine, Professor and Chair, Department of Radiation Oncology, School of Medicine, Tokyo Women's Medical University presented the summary of the PMRT clinical data of breast cancer cases. Overall 178 patients in HF-PMRT arm were enrolled during 58 months. Evaluable number of patients was 159. Only 6 patients were newly registered in this year. All patients completed protocol of treatment. The median age was 49 years old (range, 24-80). Eighty patients (50%) had left-sided breast cancer. The clinical stage was IIA in 56 patients (35%), IIB in 62 (39%), IIIA in 36 (23%), IIIB in 3 (2%), and IIIC in 2 (1%), respectively. The median treatment duration was 21 days (range, 21-84). Six patients experienced treatment interruption. Acute dermatitis of grade 2 or higher was observed in 3 patients (1%) and grade 1 acute subcutaneous toxicity was observed in 16 patients (10%). Acute grade 1 cardiac toxicity was observed in 2 patients (2%) and late grade 1 cardiac toxicity in 3 patients (2%). Late grade 1 lung toxicity was observed in 10 patients (6%). Four loco-regional recurrence, 16 distant metastases and 8 breast cancer deaths had been observed.

(21) An open discussion on the clinical data followed. Only one percent of more than grade 2 acute dermatitis and one percent grade 2 subcutaneous acute toxicity have been observed. All co-investigators are advised to re-check their data and send corrected data. Co-investigators must evaluate cosmetic outcome at 3 years and 5 years after the treatment and they are encouraged to enroll patients until next year.

Session 6: Phase II Study of Hypofractionated Radiotherapy for Breast Cancer (Whole Breast Irradiation / BREAST-I)
(22) Dr. Sawa KONO introduced and reviewed the protocol of Whole Breast Irradiation (WBI) / BREAST-I.

(23) The clinical data of Phase II Study of WBI was presented by representatives of each participating countries. The following numbers were reported: Bangladesh ( 31 ), China ( 6 ), Indonesia ( 16 ), Japan ( 137 ), Kazakhstan ( 14 ), Korea ( 9 ), Malaysia ( 0 ), Mongolia ( 3 ), Philippines ( 0 ), Thailand ( 14 ) and Vietnam ( 0 ). Total number of WBI patients was 230.

(24) Prof. Kumiko KARASAWA presented the summary of the WBI clinical data of breast cancer cases (230 patients / 231 breast lesions).

(25) Overall 231 breast lesions in HF-WBI arm were enrolled from February 2013 to October 2017. The median age of patients are 49 years. The majority of patients are in T1 (60%) N0 (86%), clinical IA (53%). Most histology is IDC (3%) and luminal B category (60%). The treatments of most patients were consistent with the protocol by using 6 MV and field in field technique. Most patients experienced no acute side effect except skin reaction (grade 2: 10%, grade 3: 2%). There were very few late adverse effects (subcutaneous effect grade 1: 10%). There was one locoregional recurrence, 3 distant metastases, 2 breast cancer deaths and 2 intercurrent deaths. In summary, all of the patients completed treatment protocol with good tumor control and very few adverse effects.

(26) An open discussion on the clinical data followed.

(27) Some data correction will be needed before manuscript submission. This report will include early results within 2-year follow-up. Long term follow-up is still needed to confirm the final results. We are expected to follow the patients every six months for 5 years and yearly thereafter.

Session 7: Review of Workshop and Future Plan
(28) Prof Shingo Kato proposed the project activities of the next year and it was agreed by all of the FNCA member states, as follows:
(29)Clinical study of 3D-IGBT for cervical cancer (CERVIX-V):

1. Enrollment of the patient will be continued;
2. The feasibility, efficacy, and acute toxicity will be assessed at annual WS

(30) Training of 3D-IGBT:

1. Hands-on training course will be held at annual WS;
2. ROs and MPs in FNCA MCs are encouraged to apply for the nuclear researcher exchange program by MEXT of Japan to study 3D-IGBT in Japanese institutes.

(31) Clinical study of NAC followed by CCRT for nasopharyngeal cancer (NPC-III):

1. Enrollment of the patient will be completed by the end of this year;
2. Follow-up of the patients will continue for > 3 years.

(32) Clinical study of hypofractionated radiotherapy for breast cancer (BREAST-I):

1. Breast conserving treatment (BCT) (Whole Breast Irradiation(WBI) ) enrollment of the patient was closed last year, follow-up of the patient will continue for > 4 years;
2. Post-mastectomy radiotherapy (PMRT) enrollment of the patient will be continued to a total number of 200, and the follow-up of the patients will continue for > 5 years.

(33) QA/QC for 3D-IGBT: audit of 3D-IGBT will start next year.

(34) Proposal of the next clinical trial.

1. Palliative RT (phase III study) (Prof. Ohno); Concept sheet will be distributed to each institute from the data center.
2. IMRT of the whole pelvis for postoperative cervical cancer (Prof. Wakatsuki), will be discussed at the next WS.

(35) Proposal of other activities. Training of delineation of CTV/OARs.

(36) The next workshop is tentatively scheduled to be held in Suzhou, China from November 11th to 17th, 2019.

Session 8: Technical Visit 1
(37) Workshop participants conducted a Technical Visit to Delta Hospital Limited while some participants started the Hands-on Training on 3D-IGBT at United Hospital Limited.

Session 9: Technical Visit 2 & Hands-on Training on 3D-IGBT
(38) The participants conducted another Technical Visit to United Hospital Ltd. Continuation of the Hands-on Training on 3D-IGBT at the same hospital.

Session 10: Open Lecture
(39) The Open Lecture was held at National Institute of Cancer Research and Hospital (NICRH). (40) Dr. Nazman Nahar moderated the Open Lecture and Prof. Mafizur Rahman welcomed the audience with his remarks.

(41) Mr. Tomoaki WADA gave a lecture about the FNCA. He introduced its overview and spoke about the on-going 7 projects' activities and achievements.

(42) Dr. Lubna Mariam, Assistant Professor, Radiation Oncology, NICRH gave a lecture on the current status of radiotherapy in Bangladesh.

(43) Prof. Tatsuya OHNO, Professor / Medical Director, Heavy Ion Medical Center, Gunma University spoke on 3D-IGBT for Cervical Cancer.

(44) Dr. Miriam Joy Calaguas, Chairman of Department of Radiotherapy,
Jose R. Reyes Memorial Medical Center (JRRMMC) gave her lecture entitled Past, Present, Future of Radiation Therapy in the Philippines.

(45) The last lecture was delivered by Prof. Masaru Wakatsuki. He gave a lecture on Particle Beam Therapy.

(46) Prof. Shingo KATO made comments on the Open Lecture.

(47) Prof. Md. Moarraf Hossen, Director, NICRH gave the closing remarks.

Session 11: Drafting Workshop Minutes
(48) Participants reviewed Technical Visit, Hands-on Training and Open Lecture.

(49) The draft of the minutes was submitted by rapporteurs, discussed and amended. The draft of the minutes will be circulated after the workshop and finalized.

(50) Prof. Shingo KATO summarized and commented on all the sessions. The workshop was closed officially with his remarks.

Program of
FNCA 2018 Workshop on Radiation Oncology Project

Day 1 Sun, 4th November 2018 / Place: Pan Pacific Sonargaon Dhaka

Day 2 Mon, 5th November 2018 / Place : Pan Pacific Sonargaon Dhaka

Day 3 Tue, 6th November 2018 / Place: Delta Hospital Limited & United Hospital Limited

Day 4 Wed, 7th November 2018 / Place: National Institute of Cancer Research and Hospital (NICRH)