臨床研究支援事業

CSPOR《がん臨床研究支援事業》

Comprehensive Support Project for Oncology Research

成果一覧

乳癌

N-SAS BC 07 (RESPECT)

第42回サンアントニオ乳がんシンポジウム/2019年12月

A cohort study to evaluate the efficacy and safety of postoperative adjuvant therapy in HER2-positive elderly breast cancer patients (RESPECT-cohort study).(相良病院 馬場 信一)

第41回サンアントニオ乳がんシンポジウム/2018年12月

Analysis of cognitive function in elderly patients with HER2-positive breast cancer receiving trastuzumab monotherapy or trastuzumab plus chemotherapy as postoperative adjuvant therapy: A cognitive function sub-study of a randomized, open-label, phase 3 clinical trial (RESPECT trial).(北海道がんセンター 高橋 將人)

第41回サンアントニオ乳がんシンポジウム/2018年12月

Patient-reported outcomes with trastuzumab monotherapy versus trastuzumab plus standard chemotherapy as a postoperative adjuvant therapy in HER2-positive elderly breast cancer patients (RESPECT): A randomized, open-label, phase 3 clinical trial. (がん研有明病院 小林 心)

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific/2018年9月

The EQ-5D index of elderly patients with HER20positive breast cancer: results from the randomized N-SAS BC 07 trial for adjuvant trastuzumab with and with our chemotherapy.(東京大学 萩原 康博)

2018 ASCO annual meeting/2018年6月

Evaluation of trastuzumab without chemotherapy as a postoperative adjuvant therapy in HER2 positive elderly breast cancer patients: Randomized controlled trial (RESPECT).(澤木 正孝 愛知県がんセンター)

第38回サンアントニオ乳がんシンポジウム/2015年12月

A randomized controlled trial of postoperative adjuvant therapy for elderly breast cancer patients: Comparison of health-related quality of life between clinical trial participants and decliners. (さいたま赤十字病院 斉藤 毅)

第38回サンアントニオ乳がんシンポジウム/2015年12月

A randomized clinical trial of postoperative adjuvant therapy for elderly breast cancer patients: Conditions of obtaining informed consent and reasons for declining participation. (相良病院 相良 安昭)


乳癌

N-SAS BC 06 (NEOS)

Spotlight Session (poster discussion), San Antonio Breast Cancer Symposium, Dec. 2021

H. Iwata, T. Toyama, N. Taira, et al. Primary analysis from NEOS trial: a randomized phase III study that assessed the long-term prognosis of estrogen receptor positive (ER+) primary breast cancer (PBC) pts who received neoadjuvant endocrine therapy (NET) with/without adjuvant chemotherapy (CT)

厳選口演 第27回日本乳癌学会総会:2019年7月

閉経後乳癌における術前内分泌療法の意義 ~ NEOS試験から得たエビデンス ( 増田慎三:国立病院機構大阪医療センター 乳腺外科)

Poster Session, San Antonio Breast Cancer Symposium, Dec. 2017

Hiroji Iwata, Norikazu Masuda, Yutaka Yamamoto, et al. T TransNEOS: Validation of the Oncotype DX Breast Recurrence Score® test on core needle biopsy samples from NEOS as predictor of clinical response to neoadjuvant endocrine therapy for postmenopausal ER+, HER2-negative breast cancer patients

Oral session, ESMO 2018 Congress, Oct. 2018

Hiroji Iwata (Aichi Cancer Center Hospital). Distant disease-free survival (DDFS) according to response category in neoadjuvant endocrine therapy (NET): 6-Year analysis in phase III NEOS trial

Poster session, San Antonio Breast Cancer Symposium, Dec. 2017

Hiroji Iwata, Yutaka Yamamoto, Takehiko Sakai, et al. NEOS: A randomized, open label, phase 3 trial of adjuvant chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole: First report of long-term outcome and prognostic value of response to neoadjuvant endocrine therapy

Poster Session, San Antonio Breast Cancer Symposium, Dec. 2015

Tomomi Fujisawa, Hiroji Iwata, Takehiko Sakai, et al. Endocrine-related symptoms during neoadjuvant endocrine therapy for breast cancer: Agreement between patient and physician reporting in a prospective clinical trial

Poster session, San Antonio Breast Cancer Symposium, Dec. 2014

Takehiro Sakai, Hiroji Iwata, Yoshie Hasegawa, et al. The first report of clinicopathological analysis at neoadjuvant treatment phase in NEOS, a randomized study of adjuvant endocrine therapy with or without chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole.

口演 第21回日本乳癌学会総会:2013年6月

術前ホルモン療法における超音波による治療効果評価(NEOSデータから得られたこと) (中島 一毅:川崎医科大学 総合外科学)

Poster session(TPS), ASCO Annual Meeting, Jun. 2013

Hiroji Iwata, Schoichiro Ohtani, Tomomi Fujisawa, et al. N-SAS BC06: A phase III study of adjuvant endocrine therapy with or without chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole (LET): the new primary endocrine-therapy origination study (NEOS).

Poster session, ASCO Annual Meeting, Jun. 2013

Shoichiro Ohtani, Naruto Taira, Kiyohiro Kihara, et al. Analysis of health-related quality of life during neoadjuvant endocrine therapy with letrozole in postmenopausal breast cancer patients: N-SAS BC06 trial

Poster session, San Antonio Breast Cancer Symposium, Dec. 2011

Iwata H, Yamaguchi T, Masuda N, et al. A randomized study of adjuvant endocrine therapy with or without chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole: An interim efficacy analysis of the new primary endocrine-therapy origination study (NEOS / N-SAS BC06)

Poster session, St. Gallen International Breast Cancer Conference, March 2009

H. Iwata, N. Masuda, T. Toyama, et al. A PHASE III STUDY OF ADJUVANT ENDOCRINE THERAPY WITH OR WITHOUT CHEMOTHERAPY FOR POSTMENOPAUSAL BREAST CANCER PATIENTS WHO RESPONDED TO NEOADJUVANT LETROZOLE: STUDY DESIGN OF THE NEW PRIMARY ENDOCRINE-THERAPY ORIGINATION STUDY[NEOS(N-SAS BC06)]


乳癌

N-SAS BC 05 (AERAS)

Oral session, San Antonio Breast Cancer Symposium, Dec. 2018

Shoichiro Ohtani (Hiroshima City Hiroshima Citizens Hospital) A prospective randomized multi-center open-label phase Ⅲ trial of extending aromatase-inhibitor adjuvant therapy to 10 years - results from 1697 postmenopausal women in the N-SAS BC 05 trial: Arimidex Extended adjuvant Randomized Study (AERAS)

Poster session, St. Gallen International Breast Cancer Conference, Mar. 2011

H. Yagata, T. Iwase, H. Ohtsu, et al. Baseline assessment of patient-reported outcomes (PROs) for breast cancer patients after 5-years of endocrine treatment in a randomized clinical trial: NSAS-BC 05

口演 日本癌治療学会:2010年10月

乳癌術後アナストロゾール服用5年終了患者に対するベースラインQOL調査(N-SAS BC 05) (聖路加国際病院 乳腺外科 矢形 寛)


乳癌

Oral Care-BC

ポスター発表 第27回日本乳癌学会学術総会:2019年7月

エベロリムス治療における予後予測因子の検討 ~Oral Care-BC登録症例での解析~ (渡邊健一:北海道がんセンター)

シンポジウム 第27回日本乳癌学会学術総会:2019年7月

がんに対する薬物療法における歯科介入効果のエビデンス(ランダム化第3相臨床試験Oral Care-BC) (太田嘉英:東海大学医学部付属病院)

Poster session, 26th ISOQOL Annual Conference, Oct. 2019

Mariko Naito, Naoki Niikura, Katsuhiko Nakatukasa, et al. Oral care to prevent oral mucositis and the health-related quality of life in estrogen receptor-positive metastatic breast cancer patients treated with everolimus (Oral Care-BC): a randomized controlled phase III trial

Poster Session, San Antonio Breast Cancer Symposium, Dec. 2018

Naoki Niikura, Katsuhiko Nakatukasa, Takeshi Amamiya, et al. Oral Care Evaluation to Prevent Oral Mucositis in Estrogen Receptor-Positive Metastatic Breast Cancer Patients Treated with Everolimus (Oral Care-BC): A Randomized Controlled Phase III Trial

Poster Session (Ongoing Clinical Trials), San Antonio Breast Cancer Symposium, Dec. 2015

Naoki Niikura, Yoshihide Ota, Naoki Hayashi, et al. Evaluation of the use of oral care to prevent oral mucositis in estrogen receptor positive metastatic breast cancer patients treated with everolimus: Phase III randomized control trial.

シンポジウム 第13回日本臨床腫瘍学会学術集会(2015年7月)

エストロゲンレセプター陽性再発乳癌を対象とした エべロリムス使用症例における口内炎予防のための 歯科介入無作為化第Ⅲ相試験 (新倉直樹:東海大学医学部 乳腺・内分泌外科)


乳癌

POTENT

POSTER 2022 San Antonio Breast Cancer Symposium

Adjuvant S-1 plus endocrine therapy for estrogen receptor-positive, HER2-negative, primary breast cancer: updated overall survival analysis from the POTENT trial (POTENT-FU) (高田 正泰:京都大学)

Lancet Oncol . 2021 Jan;22(1):74-84. doi: 10.1016/S1470-2045(20)30534-9

Adjuvant S-1 plus endocrine therapy for oestrogen receptor-positive, HER2-negative, primary breast cancer: a multicentre, open-label, randomised, controlled, phase 3 trial Masakazu Toi , Shigeru Imoto , Takanori Ishida , Yoshinori Ito , Hiroji Iwata , Norikazu Masuda , Hirofumi Mukai , Shigehira Saji , Akira Shimizu , Takafumi Ikeda , Hironori Haga , Toshiaki Saeki , Kenjiro Aogi , Tomoharu Sugie , Takayuki Ueno , Takayuki Kinoshita , Yuichiro Kai , Masahiro Kitada , Yasuyuki Sato , Kenjiro Jimbo , Nobuaki Sato , Hiroshi Ishiguro , Masahiro Takada , Yasuo Ohashi , Shinji Ohno

一般口演 第28回日本乳癌学会学術総会2020年7月

ホルモン受容体陽性乳癌の術後内分泌療法におけるS-1の併用効果(杉江 知治:関西医科大学)

General Session 2019 San Antonio Breast Cancer Symposium

Addition of S-1 to endocrine therapy in the post-operative adjuvant treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative primary breast cancer: A multicenter, open-label, phase 3 randomized trial (POTENT trial)(戸井 雅和:京都大学)


肺癌

LC07 (Reiwa)

第62回日本肺癌学会学術集会・2021年11月

EGFR遺伝子変異陽性進行非小細胞肺癌における初回オシメルチニブの効果・安全性に関する観察研究(Reiwa) (突田容子; 東北大学病院 呼吸器内科)

BMJ Open / Accepted 14 December 2021.

Efficacy and safety of first-line osimertinib treatment and post-progression patterns of care in patients with epidermal growth factor receptor activating mutation-positive advanced non-small-cell lung cancer (Reiwa study): design and rationale of a multicenter, real-world observational study (Kageaki Watanabe; Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo, Tokyo 113-8677, Japan.)


肺癌

LC05 (JP-CLEAR)

Japanese Journal of Clinical Oncology, Volume 49, Issue 6, June 2019, Pages 554–558,

Plasma ctDNA monitoring during epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor treatment in patients with EGFR-mutant non-small cell lung cancer (JP-CLEAR trial) (臼井 一裕:NTT東日本関東病院)




肺癌

LC-02

ESMO Open Cancer Horizons. DOI: 10.1136/esmoopen-2017-000214 / Published 14 September 2017

Continuing EGFR-TKI beyond radiological progression in patients with advanced or recurrent, EGFR mutation-positive non-small-cell lung cancer: an observational study (後藤 悌:国立がん研究センター中央病院)


肺癌

LC-01

Anticancer Research March 2017 vol. 37 no. 3 1507-1513

Impact of Maintenance Therapy for Patients with Non-small Cell Lung Cancer in a Real-world Setting (葉 清隆:国立がん研究センター東病院)



胃癌

REVIVE Study (GC-01)

ESMO Open, Volume 8 , Issue 6 / Published online: 27 December 2023

Chemotherapy after nivolumab for advanced gastric cancer (REVIVE): a prospective observational study(成田 有季哉:愛知県がんセンター)

ESMO-GI/2022年6月

Impact of Salvage Chemotherapy after Nivolumab Therapy (NIVO):A Sub-Study of REVIVE(松岡 宏:藤田医科大学病院)

日本胃癌学会/2022年3月4日

Efficacy of Salvage Chemotherapy (CTx) by Response to Prior Nivolumab (NIVO): A Sub-Study of REVIVE(川上 武志:静岡県立静岡がんセンター)

日本臨床腫瘍学会/2022年2月17日

REVIVE study: An Observational Study in Chemotherapy ( CTx ) after Nivolumab (NIVO) for Advanced Gastric Cancer (AGC)(坂本 康寛:大崎市民病院)

ASCO-GI/2022年1月21日

REVIVE study: A Prospective Observational Study in Chemotherapy (CTx) after Nivolumab (NIVO) Therapy for Advanced Gastric Cancer (AGC)(松島 知広:埼玉県立がんセンター)

Future Oncology, Volume 17, Issue 8 / Published online: 21 September 2020

REVIVE study: a prospective observational study in chemotherapy after nivolumab therapy for advanced gastric cancer(成田 有季哉:愛知県がんセンター)

日本臨床腫瘍学会/2019年7月18日

Chemotherapy after progREssiVe dIsease of niVolumab (NIV) thErapy (REVIVE study)(成田 有季哉:愛知県がんセンター)

日本胃癌学会/2019年2月28日

Trial in Progress: Chemotherapy after progREssiVe dIsease of niVolumab thErapy (REVIVE study)(成田 有季哉:愛知県がんセンター)

ASCO-GI/2019年1月

REVIVE study: Prospective observational study of efficacy and safety in chemotherapy after progREssiVe dIsease of niVolumab (NIV) thErapy for metastatic gastric cancer (mGC) (成田 有季哉:愛知県がんセンター)


肝細胞癌

RACB

BMC Cancer / Published on 21 August 2023

Protocol of the RACB study: a multicenter, single-arm, prospective study to evaluate the efficacy of resection of initially unresectable hepatocellular carcinoma with atezolizumab combined with bevacizumab(奥野 将之:兵庫医科大学)


肝細胞癌

LENS-HCC

日本肝癌研究会/2022年5月13日

切除不能肝細胞癌に対するレンバチニブ投与によるコンバージョン⼿術 -多施設前向き研究LENS-HCC trial-  Multicenter, single-arm trial to evaluate the efficacy of lenvatinib to achieve conversion surgery for initially unresectable hepatocellular carcinoma: LENS-HCC trial(日髙 匡章:長崎大学)

ASCO-GI/2022年1月21日

Multicenter prospective study to evaluate the efficacy of lenvatinib to achieve conversion surgery for initially unresectable hepatocellular carcinoma: LENS-HCC trial(多田 正晴:兵庫医科大学病院)

日本癌治療学会/2019年10月25日

Multicenter, single-arm trial of lenvatinib followed by surgical resection for initially unresectable hepatocellular carcinoma: LENS-HCC trial(市田 晃彦:東京大学医学部附属病院)


肝細胞癌

SURF trial付随研究

ESMO / Poster session 13・2022年9月10日

Medical expenditures and treatment efficacy of patients who had initial hepatocellular carcinoma and underwent surgery or radiofrequency ablation: Accompanying research of the SURF trial(河口 義邦:東京大学)


前立腺癌

URO 01(PROSAS-Study)

第108回日本泌尿器科学会総会 / 2020年12月

低リスク前立腺癌患者を対象とした低用量クロルマジノンの監視療法継続率に対する効果を検討する多施設共同、プラセボ対照、無作為化二重盲検群間比較試験 (PROSAS試験 )(鳥本 一匡:奈良県立医科大学)


腎癌

J-ACTOR

第54回日本癌治療学会学術集会 / 2016年10月

根治切除不能または転移性の腎細胞癌患者に対するエベロリムス投与前後のQOL変化(杉山貴之:浜松医科大学泌尿器科学講座)

第104回日本泌尿器科学会総会 / 2016年4月23日

根治切除不能または転移性の腎細胞癌患者 に対する1st line TKI療法不応後の エベロリムスの有効性および安全性の検討 ― 多施設共同第Ⅱ相試験 ―(杉山貴之:浜松医科大学泌尿器科学講座)

ASCO-GU / 2014年1月30日~2月1日

Multi-center phase II clinical trial of everolimus in Japanese patients with unresectable or metastatic renal cell carcinoma (mRCC) after failure of treatment with 1st-line tyrosine kinase inhibitor (TKI) therapy(大園 誠一郎:浜松医科大学泌尿器科学講座)