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国際研究支援室
国立がん研究センター中央病院が主導する国際共同研究の計画、準備、実施、評価、報告に関する全般的な調整事務局業務を行っています。当院は現在アジア(特にASEAN地域)における恒常的な日本主導型の国際共同医師主導治験を実施できる臨床研究ネットワーク構築を進めており、このネットワーク下で実施する様々なタイプの臨床研究(未承認薬を用いた医師主導治験やがんゲノム研究など)のプロジェクトマネジメントを行っております。海外薬事関連規制を熟知したうえで、研究タイプに応じた適切な臨床研究のオペレーション体制を提供できることが当室の強みです。JCOGとEORTC(European Organisation for Research and Treatment of Cancer)との国際共同研究、JCOGとIRCI(International Rare Cancer Initiative)の国際共同研究などを支援しています。
また、当院は経済協力開発機構(OECD)のglobal science forum (GSF)が進める臨床研究に関する国際的パートナーシップの枠組みであるClinical Research Initiative for Global Health (CRIGH)プロジェクトに参加しています。国際研究支援室では生命倫理室と協力してCRIGHの中のResearch Ethicsのプロジェクトを主導しています。
スタッフ
室長
秦 友美
主任
佐々木 哲哉
メンバー
人見 貴子、寺田 参省、石黒祥子、阿部 絹子
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国立がん研究センター中央病院
臨床研究支援部門 研究企画推進部 国際研究支援室
担当:渡邉、秦
電話番号:03-3542-2511 内線5627
Eメール:NCCH_CTM●ml.res.ncc.go.jp(●を@に置き換えてください)
主な活動(実績)
当院で実施している国際共同研究(介入研究のみ)
[ITM]:国際研究支援室が直接支援している研究
Duloxetine and Pregabalin for Neuropathic Cancer Pain (DEPARTURE)
Sponsor |
Japan |
Type |
Specified Clinical Trial |
Status |
Recruiting |
Cooperative Group |
The Palliative Care Clinical Studies Collaborative (PaCCSC) |
Participating Site |
Japan, Australia |
PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA (NRG-BN003)
Sponsor |
Overseas |
Type |
Non registration clinical trial |
Status |
Recruiting |
Cooperative Group |
NRG Oncology, FASTRO |
Participating Site |
US, Canada, Japan, Saudi Arabia |
A Randomized, Double Blind, Placebo Controlled, Phase 3 Trial for Hormone Receptor Positive, HER2 Negative Locoregionally Recurrent or Metastatic Breast Cancer(NCCH1607)
Sponsor |
NCCH [ITM] |
Type |
Registration IND ("Chiken") |
Status |
Active, not recruiting |
Cooperative Group |
Korean Cancer Study Group (KCSG) |
Participating Site |
Japan, Korea, Taiwan, Singapore |
NRG-GY004:A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer
Sponsor |
Overseas |
Type |
Registration IND ("Chiken") |
Status |
Active, not recruiting |
Cooperative Group |
NRG |
Participating Site |
US, Japan, Canada, Korea |
EORTC-1527-GITCG-IG/JCOG1609INT DREAM: Diffusion-Weighted Magnetic REsonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning
Sponsor |
Japan [ITM] |
Type |
Non-registration clinical trial |
Status |
Recruiting |
Cooperative Group |
EORTC |
Participating Site |
US, UK, France Belgium, Italy, Poland, Austria, Japan |
A Global Study To Evaluate The Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (JCOG1502C)
Sponsor |
NCCH [ITM] |
Type |
Advanced medical care B |
Status |
Recruiting |
Cooperative Group |
International Rare Cancer Initiative (IRCI) |
Participating Site |
UK, France |
Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance
Sponsor |
Overseas |
Type |
Registration IND ("Chiken") |
Status |
Active, not recruiting |
Cooperative Group |
N/A |
Participating Site |
Europe (France, Sweden, Austria, Belgium, Denmark, Finland, Germany, Italy, Japan, Monaco, Spain) |
NSABP/NRG B-51: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Sponsor |
Overseas |
Type |
Non-registration clinical trial |
Status |
Recruiting |
Cooperative Group |
NRG |
Participating Site |
US, Canada, Ireland, Israel, Korea, Puerto Rico, Japan |
A study evaluating the pregnancy outcomes and safety ofinterrupting endocrine therapy for young women with endocrineresponsive breast cancer who desire pregnancy
Sponsor |
Overseas |
Type |
Non-registration clinical trial |
Status |
Recruiting |
Cooperative Group |
International Breast Cancer Study Group (IBCSG) |
Participating Site |
Switzerland-SAKK, Australia, Italy, Belgium, Spain/Portugal - SOLTI, Greece - HORG, Slovenia, USA/Canada-Alliance/CCTG, Japan - JBCRG, Hungary, Ireland - Cancer Trials Ireland, Netherland - BOOG, Norway - NBCG, Serbia |
Treatment of Children with All Stage of Hepatoblastoma with Temsirolimus(IND#122782, NSC#683864) Added to High Risk Stratum Treatment
Sponsor |
Overseas |
Type |
Registration IND ("Chiken") |
Status |
Active, not recruiting |
Cooperative Group |
Children’s Oncology Group (COG) |
Participating Site |
US, Canada, Australia, Japan, Brasil, Puerto Rico |
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 (IntReALL SR 2010) A randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group
Sponsor |
Overseas |
Type |
Non-registration clinical trial |
Status |
Not recruiting |
Cooperative Group |
BFM study group |
Participating Site |
Europe (Germany, Italy, France, UK, Japan, Netherland, Australia, etc.) |
Stage and Site Specific Sensitivity of Fecal Immunochemical Tests for Large Advanced Adenoma and Cancers - A Prospective Multi-National, Multi-Center Study
Sponsor |
NCCH |
Type |
Non-registration clinical trial |
Status |
Completed |
Cooperative Group |
N/A |
Participating Site |
Taiwan |
A Multinational, Randomized, Phase III Study of XELIRI with/without Bevacizumab versus FOLFIRI with/without Bevacizumab as Second-line Therapy in Patients with Metastatic Colorectal Cancer
Sponsor |
Japan |
Type |
Non-registration clinical trial |
Status |
Completed |
Cooperative Group |
N/A |
Participating Site |
Japan, Korea, China |
A phase II trial of neoadjuvant imatinib for large gastric GIST in Asia
Sponsor |
Japan |
Type |
Non-registration clinical trial |
Status |
Completed |
Cooperative Group |
N/A |
Participating Site |
Korea, Taiwan |
Prospective cohort study evaluating the long-term outcome after endoscopic submucosal dissection for colorectal neoplasia
Sponsor |
NCCH |
Type |
Non-registration clinical trial |
Status |
Active, not recruiting |
Cooperative Group |
N/A |
Participating Site |
Australia |
Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer
Sponsor |
NCCH [ITM] |
Type |
Non-registration clinical trial |
Status |
Active, not recruiting (Japan)/ Competed (US) |
Cooperative Group |
NCCTG |
Participating Site |
US, NCCTG |
A PHASE II EVALUATION OF TEMSIROLIMUS (CCI-779) (NCI SUPPLIED AGENT:NSC# 683864, IND# 61010) IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL FOLLOWED BY TEMSIROLIMUS (CCI-779) CONSOLIDATION AS FIRST-LINE THERAPY IN THE TREATMENT OF STAGE III-IV CLEAR CELL CARCINOMA OF THE OVARY
Sponsor |
Overseas |
Type |
Registration IND ("Chiken") |
Status |
Completed |
Cooperative Group |
GOG |
Participating Site |
US, Korea |
REGATTA: A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor
Sponsor |
Japan [ITM] |
Type |
Non-registration clinical trial |
Status |
Completed |
Cooperative Group |
Korean Gastric Cancer Association (KCGA) |
Participating Site |
Korea |
A Phase III randomized controlled clinical trial of CARBOPLATIN and PACLITAXEL(OR GEMCITABINE) alone or in combination with BEVACIZUMAB (NSC #704865, IND #7921) followed by BEVACIZUMAB and secondary cytoredutive surgery in platinum sensitive, recurrent ovarian, peritoneal primary and fallopian tube cancer.
Sponsor |
Overseas |
Type |
Registration IND ("Chiken") |
Status |
Completed |
Cooperative Group |
GOG |
Participating Site |
US, Korea |