(1) Following the agreement of the 7th Forum for Nuclear Cooperation in Asia (FNCA) Coordinators Meeting in March 2006, and the 6th FNCA Meeting in January 2006, the FNCA FY2006 Workshop on Radiation Oncology was held from January 9 to 13, 2007, in Hanoi & Ho Chi Minh City , Viet Nam . The meeting was organized by the National Cancer Institute of Viet Nam (K Hospital) and co-hosted by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan , in cooperation with the Japan Atomic Industrial Forum, Inc. (JAIF). Representatives from 8 FNCA countries, namely China , Indonesia , Japan , Republic of Korea , Malaysia , the Philippines , Thailand and Vietnam , participated in the workshop. A representative from Bangladesh participated as an observer.

Opening ceremony in Hanoi

(2) Dr. To Anh Dung, National Cancer Institute of Viet Nam (K Hospital), acted as the moderator. The welcome remarks were delivered by Dr. Nguyen Ba Duc, K Hospital. He stressed the important role of radiotherapy against cancer, which is the second common cause of death in Viet Nam . Dr. Bui Van Tuan, Vietnam Atomic Energy Commission (VAEC), in his remarks explained that the national strategy against cancer was approved by the Ministry in January 2006, and further stressed the importance of international network. Dr. Tran Thi Giang Huong, International Cooperation Department, Ministry of Health, Viet Nam , expressed the importance of joint effort with participating countries in her welcome remarks. Finally, on behalf of participating countries, Dr. Hirohiko Tsujii, National Institute of Radiological Sciences (NIRS), Japan , expressed his appreciation to Viet Nam for hosting the workshop. He also explained the FNCA framework and welcomed participation of Bangladesh as an observer.

(3) Dr. Nguyen Ba Duc, K Hospital, gave a Special Lecture on the present status of radiation therapy in Viet Nam and the future plans which includes setting up of a new National Cancer Institute. Dr. Hirohiko Tsujii, Japan , explained the history of this FNCA project, and the objectives of this meeting.

The agenda was adopted; chairpersons and rapporteurs were selected. (See Attachment 1) The new participants, Dr. Yang, China , and Dr. Tang, Malaysia , were introduced. Dr. Alam , Bangladesh , was introduced later.

Session1: Phase 2 Study of Chemo-radiotherapy for Uterine Cervix Cancer (CERVIX-III)

(4) The status of registered Cervix-III patients was presented by each country. (The number of patients: China 18, Indonesia 5, Japan 32, Korea 10, Malaysia 14, the Philippines 12, Thailand 19 and Viet Nam 10.) Dr. Shingo Kato, Japan , presented the accumulated clinical data for 120 cases. The follow up rate is 91%. About acute toxicities, Grade 3 leukopenia was 21%. In non-hematological toxicities, upper GI symptoms (Grade 3 or greater) was 6%. So, acute toxicities were considered acceptable. With the median follow up of 18.6 months, the data showed: 87.6% 2y local control, 68.5% 2y progression free survival rate, and 76.5% 2y over-all survival rate. Among late complications, there were three Grade 3 - 4 rectum/sigmoid late toxicity. Further follow up is deemed necessary to monitor the tomour response, late toxicities and over-all survival rate.

Session2: Prophylactic PALN RT / Adjuvant Chemotherapy for Uterine Cervix Cancer

(5) Dr. De los Reyes, the Philippines , reported clinical results of concurrent chemoradiotherapy with CDDP 75mg/m2 on d1, 22, and 43 for 14 cases and expressed his opinion of the necessity for further improvement of the treatment. Dr. Kato, Japan, reported patterns of failure for 28 para-aortic lymph node (PALN) negative patients from Cervix III study and proposed a clinical trial of prophylactic PALN radiotherapy (RT) for advanced cervical cancer as our new cooperative study. Dr. Ohno, Japan , reported the efficacy of prophylactic PALN RT for advanced cervical cancer by reviewing some published clinical results including RTOG 79-20 and EORTC trials . Dr. Thephamongkhol reviewed the role of adjuvant chemotherapy in advanced stage cases. Based on these presented data, the role of prophylactic PALN RT was discussed.

Session3: New Clinical Trial for Locally Advanced Cervical Cancer

(6) After a thorough discussion on the PALN RT and adjuvant chemotherapy, the following 4 options were further suggested.

1. Concurrent CRT to pelvis only
2. 1. Concurrent CRT to pelvis followed by PALN RT (sequential)
   2. Concurrent CRT to extended field (RT to pelvis and PALN)
3. Concurrent CRT (pelvis) followed by adjuvant CT

Bangladesh and China voted for I., Japan for II.1. and II.2., the Philippines for II.2. and III., Thailand for III, and rest of the countries for II.2. After some more discussion, option II.2. was finally chosen. Dr. Tsujii suggested that, as toxicities have not been tested, Phase I/II trial should be done. The meeting then discussed the eligibility criteria of the new protocol; only PS 0-1 should be included. CDDP dose would be kept as 40mg/m2, but dose modification was suggested depending on the grade of acute toxicities. Dr. Kato will draft the new protocol and circulate it via e-mail by March 2007.

Session4: Phase 2 Study of Chemoradiotherapy for NPC (TxN2-3) (NPC-I)

(7) The status of registered NPC-I patients were presented by each country. (The number of patients: China 3, Indonesia 3, Malaysia 15, the Philippines 3, Thailand 5. Korea and Viet Nam presented 5 and 135 non protocol cases without adjuvant chemotherapy, respectively.)

(8) Dr. Tatsuya Ohno, Japan , presented accumulated data of the Phase 2 Study, NPC-I. The number of registered patients was 28. All patients completed radiotherapy; 46% needed interruption. Eighty three % completed at least 4 cycles of concurrent chemotherapy (CTX), while 36% of the patients could not complete adjuvant chemotherapy. About hematological toxicities, no patients showed Grade 4 toxicities during concurrent CTX and 4 patients showed Grade 4 during adjuvant CTX. About non-hematological toxicity, one patient had Grade 4 mucositis and one had Grade 4 pain during concurrent CTX; no patient showed Grade 4 toxicity during adjuvant CTX. Compared with published studies, the incidence of severe nausea/vomiting and leucopenia was low, although that of severe mucositis was similar. Tumor clearance rate at the stipulated 6 months could not be calculated because of the low compliance rate of CTscan studies (8 out of 28, 29%). Further follow up is deemed needed.

(9) Since many institutions did not perform CT scan at 6 months after the treatment, this policy was reconsidered. The target number of patients, 25, was also discussed. The decision was deferred to next session.

(10) A role of adjuvant chemotherapy was presented by Dr. Thephamongkhol, Thailand . Based on literature review, he surmised that higher incidence of distant metastasis could be due to inadequate local control.

Session5: Session 5: Phase 2 Study of Chemoradiotherapy for NPC (T3-4N0-1) (NPC-II)

(11) Dr. Ohno presented accumulated data of NPC-II (protocol without adjuvant CTX). The number of registered patients was 31. One patient did not complete radiotherapy; 13 % needed interruption. Eighty six % of the patients completed at least 4 cycle of CTX. About hematological toxicities, one patient had Grade 4 anemia. No patient showed Grade 4 non-hematological toxicities. The rate of severe nausea/vomiting and leucopenia is considered low.

(12) Future plan of NPC study was discussed. Modification of protocol was decided as follows: The sample size should be increased enough to examine 3-year over-all survival rate, for both NPC-I and II. The exact number will be calculated by Dr. Kobayashi at a later date. Thus, the both studies are still open for recruitment of patients.

Session6: QA/QC of Radiation Dosimetry

(13) Dr. Tang Tieng Swee, Malaysia , reported status of medical physics in Malaysia , including MINT-SSDL system, and the situation in the Sarawak General Hospital . Dr. Hideyuki Mizuno , Japan , explained Quality Assurance / Quality Control (QA/QC) for teletherapy and audit system in general. He also introduced the QA status of Japan .

(14) Dr. Yuzuru Nakamura, Japan , reported the completed field survey for brachytherapy, which had been conducted from FY2002 to FY2006 in 16 hospitals in 8 countries. The measurement of Ir-HDR machines' activities showed the deviation within +/- 3%. The accuracy of dose at point A calculated by RTPs showed the deviation within +/- 4%. The results were considered satisfactory.

(15) Dr. Mizuno, Japan , explained future plan for postal teletherapy audit. The audit is being performed with postal service of glass dosimeters and tough water phantoms. He tried the system in November 2006 in China , and the dose deviation was within +/-2%. The postal audit will be conducted for Korea in January-February 2007. The aim is to complete the audit in all countries by the end of 2007.

Session 7: Technical Visit at the 108 Army Central Hospital and National Cancer Institute

(16)The participants conducted a Technical Visit to the 108 Army Central Hospital and observed its Cyber Knife system. They subsequently visited the National Cancer Institute and observed the radiation oncology department.

Session 8: Open Lecture in Hanoi

(17) The first open lecture was held at the National Cancer Institute (K hospital) as a part of the workshop. There were around 45 participants including medical doctors, medical physicists and researchers. Three lectures were given by FNCA participants. (Attachment 1)

(18) Finally, a Special Lecture on the Future Plan of Radiation Therapy in Viet Nam was given by Dr. Vuong Huu Tan, Vietnam Atomic Energy Commission (VAEC). He introduced peaceful use of nuclear energy in Viet Nam and the role of VAEC

Session 9: Technical Visit to Ho Chi Minh City Oncology Hospital

(19) The participants conducted a Technical Visit to the Ho Chi Minh City Oncology Hospital and saw the radiation oncology department, including the new Linear Accelerator Center.

Opening Session in Ho Chi Minh City (HCMC)

(20) Dr. Dang Huy Quoc Thinh, Ho Chi Minh City Oncology Hospital , acted as the moderator. The welcome remarks were delivered by Dr. Pham Xuan Dung, Deputy Director, Ho Chi Minh City Oncology Hospital , followed by remarks of Dr. Hirohiko Tsujii, National Institute of Radiological Sciences (NIRS), introducing the FNCA project.

Session 10: Open Lecture in HCMC

(21) The second open lecture was held as part of the workshop. There were around 80 participants including surgical oncologists, medical oncologists, radiation oncologists, medical physicists and students. Five lectures were given by FNCA participants. (Attachment 1)

Session 11: Future plan, other activities

(22) Dr. Hideo Tatsuzaki, Japan , presented a draft questionnaire on the status of cancer treatment. The survey of the number of patients treated by radiation therapy and other modalities in the participating hospitals was proposed and decided after some modification.

(23) Dr. Tsujii informed the group that the next evaluation of the project will be at the end of the fiscal year 2007. Therefore, all data should be ready by that time.

(24) Future plans were discussed and approved.

These include: The schedule of NPC-I and NPC-II protocol were modified and extended to accrue more patients. The exact number will be calculated and informed later. The follow up sheets will be sent out once a year in September and the data should be sent back to the registration center one month before the next meeting. The new QA/QC activity for external beam therapy will continue and finish in 2007. The draft article of Cervix II is under preparation and will be submitted to an international journal. Reports to ASTRO, ESTRO, or local societies are encouraged.

(25) The meeting suggested the Philippines as the venue for the next workshop subject to an agreement of the Government of the Philippines and accepted it's tentative schedule as January 21-27, 2008.

Session 12: Drafting the Workshop Minutes

(26) The draft minutes presented by rapporteurs were discussed, amended and adopted.

Closing ceremony

(27) Participants expressed appreciation to MEXT, K Hospital , Ho Chi Minh City Oncology Hospital , local staff organizing the meeting, and JAIF. The participants especially expressed their gratitude for the continuing support from the Government of Japan for this project. Closing Remarks were given by Dr. Tsujii, who expressed his appreciation to the host institute and participants as well as his expectations for the future of the project.

Session 12: Tour

(28) The participants joined a tour arranged by the National Cancer Institute.

Venue & Stay:

January 9 - 13, 2007, Viet Num

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