dedicated to the advancement of cancer clinical trialspositive, her2-negative metastatic breast...
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KCSG: Paving the way to a cancer-free world
Contact info e-mail. [email protected] website. www.kcsg.org
Address 4F, 15, Teheran-ro 84-gil, Gangnam-gu, Seoul 06179, Rep. of Korea
Dedicated to the advancement of cancer cl inical trials
2020 Brief Annual Report
Korean Cancer Study Group (KCSG) is the nation’s leader in multi-institutional clinical trials for cancer treatment.
Since our establishment in 1998, KCSG has been dedicated to the advancement of clinical and translational cancer research through multi-institutional clinical trials in Korea.
WHO WE ARE
• KCSG: Paving the way to a cancer-free world
KCSG AT A GLANCE
RESEARCH FIELD
• To design and conduct practice changing clinical trials
• To promote international collaborative cancer research
• To optimize multidisciplinary team science in cancer research
• To implement education and training on cancer treatments and clinical trials
• To improve public access to cancer clinical trials
GOAL
VISION
Individual members dedicated cancer research
Cancer centers & hospitals in Korea
Publications Alliances with global study groups
Clinical studies since 1998 Enrolled patients
850+ 110+
80+ 6+
180+ 36,000+
• Hepatobiliary & Pancreatic Cancer
• Genitourinary Cancer & Gynecologic Cancer
• Head & Neck and Esophageal Cancer
• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Stomach Cancer
• Lymphoma
• Palliative Care
• Rare Cancer
KCSG
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
• 850+ members from 110 hospitals and institutions in Korea • Clinical oncologists across all oncology disciplines • Highly interconnected national network for efficient global clinical trials • Well-trained healthcare professionals including CRAs, CRCs, CRPs, and members of CRO
MEMBERSHIP ORGANIZATION
654Seoul-Gyeonggi-Incheon
Gyeongsang Province
Gangwon Province
Jeolla Province
Chungcheong Province
Jeju Island
130
20
627
59
Administrative TeamQuality Assurance Committee
Board of Directors
Steering Committee
Executive Committee
Data Center
Disease Committee
Breast Cancer CommitteeProtocol Review Committee Project Management
Colorectal Cancer CommitteeInstitutional Review Board Monitoring CRAs
Inhouse CRAs
Business Development
Data Management
Regulatory Affair / Pharmacovigilance
GU/GY Cancer CommitteePlanning Committee
Lymphoma Committee
External Cooperation Committee
Stomach Cancer Committee
Translational Research Committee
Rare Cancer Committee
General Affairs
Fundraising committee
Palliative Care Committee
Public Relations Committee
Lung Cancer Committee
Education Committee Head & Neck and Esophageal Cancer Committee
Hepatobiliary & Pancreatic Cancer Committee
members
members
members
members
members
members
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
KCSG'S HISTORY
1998 Established KCSG, consisting of six committees: Stomach Cancer,
Colorectal Cancer, Lung Cancer, Head & Neck and Esophageal Cancer,
Breast Cancer, and Lymphoma
2002 Founded Hepatobiliary & Pancreatic Cancer Committee
2003 Hosted the 1st Clinical Trial Workshop
2004 Founded Palliative Care Committee
2005 Set up Institutional Review Board (IRB)
2006 Research Support Department renamed to Data Center
2007 [KCSG LU02-01] Research published: J Clin Oncol. 2007;25:5233-9
2009 Founded GU/GY cancer committee and rare cancer committee
Founded Protocol Review Committee (PRC)
Implemented KCSG-ECOG-ACRIN (Eastern Cooperative Oncology Group)
research cooperation
2010 [KCSG HB06-02] Research published: Cancer Chemother Pharmacol, 2010
Mar;65(4):641-7
2011 [KCSG ST06-04] Research published: Invest New Drugs, 2011;29:366-73
Joined ECOG as special participant member
2013 [KCSB BR07-02] Research published: J Clin Oncol. 2013;31:1732-9
2014 [KCSG LY04-03] Research published: Oncologist, 2014;19:1129-30
Entered partnership with TRIO(Translational Research in Oncology) for joint
research, received TRIO grant
Started exchange program with AGITG (Australasian Gastro-Intestinal
Trials Group)
2015 [KCSG LU05-04] Research published J Clin Oncol. 2015 Aug 20;33(24):2660-6
[KCSG GU10-17] Research published Br J Cancer. 2015;112:260-5
[KCSG HN12-02] Research published Clin Cancer Res. 2015 Feb;21(3):544-52
Participated in collaborative research with EORTC (European Organization for
Research and Treatment for Cancer)
Participated in research of CTCG (Canadian Cancer Trials Group)
2016 Endorsed by Ministry of Food and Drug Safety
2017 [KCSG LU13-08] Research published J Clin Oncol. 2017 Aug 10;35(23):2613-2618
Became a member of Breast International Group (BIG)
Established QA Committee and Translational Research Committee
2018 [KCSG PC13-09] Research published Br J Cancer. 2018 May;118(9):116901175
Hosted KCSG-KoNECT-ECRIN joint workshop
2019 Consolidated IRB Committee into PRC Committee
Hosted Clinical Trial Networking Night at ASCO 2019 (Co-host: KoNECT)
2020 [KCSG LU15-09] Research published J Clin Oncol. 2020 Feb 10;38(5):488-495
Opened online training program for cancer clinical trial professionals
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
LANDMARK TRIALS
Ther Adv Med Oncol. 2019 Aug 23;11:1-9
Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group.
Lancet Oncol. 2014 Oct;15(11):1245-53.
Oxaliplatin, fluorouracil, and leucovorin versus fluorouracil and leucovorin as adjuvant chemotherapy for locally advanced rectal cancer after preoperative chemoradiotherapy (ADORE): an open-label, multicentre, phase 2, randomised controlled trial.
KCSG HN14-01 / Cancer. 2017 Jun 1;123(11):1958-1964.
Clinical Trial of Nintedanib in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck:A Multicenter Phase 2 Study (Korean Cancer Study Group HN14-01)
KCSG LY16-01 / Cancer Res Treat. 2018 Apr;50(2):590-598.
Multicenter Retrospective Analysis of Clinical Characteristics, Treatment Patterns, and Outcomes in Very Elderly Patients with Diffuse Large B-Cell Lymphoma: The Korean Cancer Study Group LY16-01
KCSG GU10-16 / Eur J Cancer. 2020 Mar;127:183-190.Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16).
Hepatobiliary & Pancreatic Cancer
Colorectal Cancer
GU&GY Cancer
Head & Neck and Esophageal Cancer
KCSG PC13-09 / Br J Cancer. 2018 May;118(9):1169-1175.Predicting cumulative incidence of adverse events in older patients with cancer undergoing first-line palliative chemotherapy: Korean Cancer Study Group (KCSG) multicentre prospective study.
KCSG ST10-01 / Oncologist. 2019 Jan;24(1):18-e24.A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01).
KCSG BR15-10 / Lancet Oncol. 2019 Dec;20(12):1750-1759Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial.
KCSG BR10-04 / Eur J Cancer. 2018 Nov;103:127-136. Fulvestrant plus goserelin versus anastrozole plus goserelin versus goserelin alone for hormone receptor-positive, HER2-negative tamoxifen-pretreated premenopausal women with recurrent or metastatic breast cancer (KCSG BR10-04): a multicentre, open-label, three-arm, randomised phase II trial (FLAG study)
Lung Cancer
Lung Cancer
KCSG LU15-09 / J Clin Oncol. 2020 Feb 10;38(5):488-495. Osimertinib for Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09)
KCSG LU13-08 / J Clin Oncol. 2017 Aug 10;35(23):2613-2618Open-Label, Multicenter, Phase II Study of Ceritinib in Patients With Non-Small-Cell Lung Cancer Harboring ROS1 Rearrangement.
Lymphoma
Palliative Care
Stomach Cancer
Breast Cancer
Breast Cancer
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
WHAT WE DO KCSG'S CLINICAL TRIAL PROCEDURE
Research
Idea (PI)
Start
Protocol
Review
Committee
Protocol
Review
Committee
Protocol &CRF
development
from PI
Research
Completion
Disease Committee
DATA Center
PI
Clinical Trial Operation
Data Management
Stat/CSR Writing
Recruit/select
participating
institutions
Ongoing
End of follow-up
Final analysis report
Publication
Proposal
Approval
Submission
Synopsis Pre-review,
Discuss & Advise
Review,
Discuss & Advise
Approval
Admin Team
• Research support for efficient implementation of multi-
institutional clinical cancer studies
• Public relations to improve public’s understanding of clinical
cancer research
• Domestic & international cooperation programs for cancer
researchers and research institutions
• Implementation of policy studies for developing regulations
and policies on clinical cancer research
• Education programs to nurture specialized professionals in
clinical cancer research
• Scientific/academic conference for researchers
to encourage academic collaboration
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
RESEARCH ACCOMPLISHMENTS
clinical researches since 1998194
DATA CENTERis a clinical operation organization in KCSG.We provide high-quality clinical operational services to study sponsors, complying with ICH guidelines, Korean GCP and relevant regulations.
Data Management
IND/IRB Affairs
Project Management
Our Services
EDC Set Up Maintenance
Site Managementfrom initiation to close-out activities including monitoring
Professional Clinical Operation
Statistics&Medical Writing
KCSG
Achievement
Publication
9080706050403020100
2020
6
2019
15
2018
8
2017
6
2016
7
2015
7
2014
6
2013
4
2012
5
2011
2
2010
2
2009
7
2008
7
2007
2
2006
1
2005
2
36
35
12
26
1 915Colorectal Cancer
23Head & Neck and
Esophageal Cancer
11lymphoma
19Genitourinary Cancer
& Gynecologic Cancer
7Palliative Care
Stomach
Cancer
Lung Cancer
Breast Cancer
Rare Cancer Others Hepatobiliary &
Pancreatic Cancer
years of paving the way to a cancer-free world22
19443 27 13 111
Research progress
Ongoing, recruiting patients
Ongoing, but not recruiting Preparing Closed
Total
Landmark Trials
AS OF OCT 2020
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
Disease Committee
Phase Study No. Study Name
Breast Cancer
II KCSG BR17-04phase II trial of durvalumab and tremelimumab in the hormone receptor-positive, hyperMUTATed metastatic breast cancer Identified by whole exOme sequencingN (‘MUTATION1’)
Ib&II KCSG BR18-10Phase IB & II study of Ribociclib with Trastuzumab plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients
II KCSG BR18-13Phase II Study of Trastuzumab plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy
II KCSG BR18-14
Open label, multicenter, prospective phase II study to investigate the efficacy and safety of Trastuzumab biosimilar (Herzuma®) plus treatment of physician’s choice (TPC) in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy
Ib&II KCSG BR18-16A Phase IB/II, Single arm, Multi-center Study of Nivolumab in Combination with Eribulin in HER2 negative Metastatic Breast Cancer patients
II KCSG BR18-21
Randomized, Phase II Trial to Evaluate the Efficacy and Safety of Atezolizumab plus capecitabine Adjuvant Therapy compared to Capecitabine monotherapy for Triple Receptor-Negative Breast Cancer with Residual Invasive Cancer after Neoadjuvant Chemotherapy
II KCSG BR18-22Phase II trial of pembrolizumab in hormone receptor-positive, hyperMUTATted metastatic breast cancer Identified by whole exOme sequeNcing (‘MUTATION2’)
II KCSG BR19-03
Randomized, Open label, Multi-Center, Phase II Trial of Eribulin with or without SB3 (Trastuzumab-biosimilar) in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens
NA KCSG BR19-10
Epidemiologic Evaluation and Clinical Outcomes for HER2-negative Metastatic Breast Cancer (MBC) Patients with Germline BRCA1 and 2 Pathogenic Mutation in Korea : Multi-Institutional Prospective Study to Investigate Prevalence & Clinical Outcomes
II KCSG BR19-13Single-arm Phase II Study of Palbociclib Plus Endocrine Therapy in Patients With High Risk ER-positive/HER2-negative T1-2N0-1 Early Breast Cancer Incorporating GenesWell™ BCT
III KCSG BR19-20 (TRIO033)
A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2- negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE)
ONGOING TRIALS AS OF OCT 2020
Breast Cancer
II KCSG BR19-21Phase II Study of Abemaciclib plus Trastuzumab biosimilar(Herzuma®) ± Fulvestrant in Patients with HER2 Positive Metastatic Breast Cancer in Brain who Progressed after HER2 directed Chemotherapy
NA KCSG BR20-01Molecular profiling using FoundationOne CDx in young (≤50 years of age) patients with metastatic breast cancer(ML41263)
II KCSG BR20-13 (TRIO038)
A randomized, multicenter, open-label, two-arm, phase ii, neoadjuvant study evaluating the efficacy, safety, and pharmacokinetics of gdc-9545 plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with estrogen receptor-positive and her2-negative untreated early breast cancer
Colorectal Cancer
NA KCSG CO15-07Pattern of use of Bevacizumab or Cetuximab in patients with metastatic colorectal cancer when added to FOLFIRI regimen as first-line treatment;multi-centre, registry study
II KCSG CO17-02
Preoperative Chemoradiotherapy with Capecitabine with or without Temozolomidein Patients with Locally Advanced Rectal Cancer; A Prospective Randomised Phase 2 Study Stratified by MGMT(O6-methylguanine DNA methyltransferase) status
II KCSG CO19-18
A randomized, open-label, multicenter phase II study of bevacizumab, infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (A-FOLFOXIRI) compared with bevacizumab, infusional fluorouracil, leucovorin, and irinotecan/oxaliplatin (AFOLFIRI/FOLFOX) as first-line treatment for metastatic right-sided colon cancer
GU&GY Cancer
III KCSG GU16-02FOur Cycles of Cisplatin-Based Chemotherapy in Metastatic Urothelial Carcinoma Compared to Six Cycles: Randomized Phase III Trial ? (FOCUS study)
III KCSG GU16-05
A Prospective Randomized Phase III Trial of Maintenance Pemetrexed versus Observation in Patients with Recurrent or Metastatic Urothelial Carcinoma who completed first line platinum-based chemotherapy without disease progression
II KCSG GU18-18An open label, single-arm, multi-center phase II study to evaluate the safety and efficacy of Herzuma® in combination with Paclitaxel in HER2-positive recurrent/metastatic urothelial carcinoma (KM-14)
NA KCSG GU20-02A Retrospective study to evaluate the comparative analysis to Axitinib versus Cabozantinib in pre-treated Patients with Advanced renal cell cancer as 2nd line treatment
II KCSG GU20-03A Multicenter Prospective Phase II Study of modified FOLFIRINOX for 1st line treatment for advanced urachus cancer
NA KCSG GU20-07Multicenter retrospective evaluation of adherence to treatment guidelines of germ cell tumor and implication of treatment outcome
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
Head&Neck, and
Esophageal Cancer
II KCSG HN18-07A phase II trial of neoadjuvant docetaxel/5-FU/cisplatin in combination with prophylactic Pegteograstim in unresectable, locally advanced nasal cavity/paranasal squamous cell carcinoma (SCC)
II KCSG HN19-09A randomized phase II study of consolidation pembrolizumab therapy after chemoradiotherapy in locally advanced nasopharyngeal carcinoma
III KCSG HN19-23
Randomized Phase II trial of a PD-1 inhibitor INCMGA00012 as consolidation therapy after definitive concurrent chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma (RHAPSODY)
Hepatobiliary & Pancreatic
CancerII KCSG HB19-14
A phase II trial of trastuzumab-pkrb combined with modified FOLFOX-6 in Biliary tract cancer patients progressed on first line therapy.
Lung CancerLung
Cancer
II KCSG LU15-04Phase II trial of paclitaxel (T) vs Irinotecan(I) in patients with previously Etoposide/platinum (EP) treated, extensive disease (ED) small cell lung cancer (SCLC) as 2nd line chemotherapy
III KCSG LU15-12
Randomized phase 3 study of intercalating combination of adjuvant chemotherapy and Gefitinib versus adjuvant chemotherapy alone following complete tumor resection in non-small cell lung cancer (NSCLC) patients with common EGFR mutations
NA KCSG LU15-14Identification of Genomic Landscape of Korean Patients with Lung Cancer through Establishment of Database for Molecular Genotyping
NA KCSG LU17-13Prospective cohort and analysis of clinical outcomes of ROS1-rearranged patients with non-small-cell lung cancer
II KCSG LU17-17"The Effect of EGFR TKI Treatment Based on Liquid Biopsy Panel Screening in Patients with Non-Small Cell Lung Cancer"
III KCSG LU19-04Study of Atezolizumab in Combination with Carboplatin + Paclitaxel +Bevacizumab vs with Pemetrexed + Cisplatin or Carboplatin with Stage IV Non-Squamous Non-Small Cell Lung Cancer with EGFR(+) or ALK(+)
NA KCSG LU19-22TOAST: Totality Outcome of Afatinib Sequential Treatment in patients with EGFR sensitizing mutation-positive NSCLC in South Korea
II KCSG LU19-24Phase II study of durvalumab, doxorub icin, and ifosfamide in pulmonary sarcomatoid carcinoma
II KCSG LU19-01Randomized phase II study of pembrolizumab q 12 weeks versus q 3 weeks in NSCLC with clinical benefit to pembrolizumab monotherapy : Multicenter International Study
NA KCSG LU20-11
A retrospective multicenter study for long-term outcomes in patients with advanced and/or metastatic non-small cell lung cancer who completed two years of immune checkpoint inhibitors or who achieved durable response but discontinued due to other causes except disease progression
Lymphoma
NA KCSG LY17-08Clinical outcomes of R-miniCHOP in elderly patients older than 80 years with diffuse large B cell lymphoma: registry
II KCSG LY18-11Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma
NA KCSG LY18-01Clinical outcomes and prognostic factors in patients with advanced-stage extranodal NK/T-cell lymphoma: Korean multicenter retrospective study
NA KCSG LY20-06Multicenter retrospective analysis of clinical characteristics, treatment patterns, and outcomes in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma
Rare Cancer
NA KCSG RC20-09Clinical outcomes of Extra-mammary Paget’s disease in Korea: A multicenter, retrospective study
II KCSG UN14-13A phase II study to evaluate the efficacy of regorafenib in c-kit mutated metastatic malignant melanoma failed First-Line dacarbazine or temozolomide contained therapy.
II KCSG UN18-06Phase II Trial of Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment
NA KCSG UN18-09Clinicopathologic characterization of the rare cancer in Korea: multi-center retrospective study
II KCSG UN18-15Phase II trial, Multicenter, First line Paclitaxel-Avelumab Treatment for Inoperable Angiosarcoma
Stomach Cancer
III KCSG ST14-05Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer
III KCSG ST15-08
A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) who Received Radical Resection
III KCSG ST17-20
A multicenter, randomized, open label, phase III trial to evaluate the efficacy and safety of the combination of S-1, oxaliplatin, irinotecan in comparison to the combination of cisplatin and S-1 as first-line treatement in patients with metastatic or relapsed gastric cancer
Ib&II KCSG ST18-03Durvalumab(MEDI4736)/tremelimumab plus paclitaxel in patients with hypermutated gastric cancer who fail a first-line chemotherapy
Ib&II KCSG ST18-20Phase1b/2 study of AZD8186 in combination with paclitaxel in patients with advanced gastric cancer
NA KCSG ST20-04The Master Protocol for Cancer Genomic Screening in Patients with Advanced Gastric Cancer
All Cancer
II KCSG AL19-17A phase II Study of Tepotinib(MSC2156119J) in Patients with solid cancers harboring c-MET amplification or exon 14 mutation Who Progressed after Standard treatment for Metastatic disease
OS KCSG AL20-05Korean Precision Medicine Networking Group Study of Molecular profiling guided therapy based on genomic alterations in advanced Solid tumors (KOSMOS)
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KCSG; KOREAN CANCER STUDY GROUP DEDICATED TO THE ADVANCEMENT OF CANCER CLINICAL TRIALS
PUBLICATIONS IN 2019 - 2020 GLOBAL COOPERATIVE ACTIVITIESCooperative
GroupStudy No. Study Name
ECOG-ACRIN S1007
A Phase III, randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER2-negative breast cancer with recurrence score (RS) of 25 or less. RXPONDER: A clinical trial RX for positive node, endocrine reponsive breast cancer
TRIO TRIO 033
A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAL with Ribociclib [LEE011]: NATALEE).
TRIO TRIO 038
A randomized, multicenter, open label, two arm, phase II, neoadjuvant study evaluating the efficacy, safety, and pharmacokinetics of GDC 9545 plus palbociclib compared with anastrozole plus palbociclib for postmenopausal women with estrogen receptor positive and HER2-negative untreated early breast cancer
TRIO TRIO 041
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of regorafenib in combination with nivolumab versus transarterial chemoembolization (TACE) for the first-line treatment of intermediate-stage hepatocellular carcinoma with beyond up-to-7 criteria
BIG BIG 16-05
IMpassion030
A phase III, multicenter, randomised, open-label study comparing atezolizumab (anti PD-L1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triple negative breast cancer (TNBC).
BIG DECRESCENDO De-escalation of adjuvant chemotherapy in HER2-positive, estrogen receptor-negative, node-negative early breast cancer subjects who achieved pathological complete response after neoadjuvant chemotherapy and dual HER2-blockade.
EORTC 1203 GITCG Integration of trastuzumab, with or without pertuzumab, into perioperative chemotherapy of HER-2 positive gastric cancer, with multicenter validation of early PET as predictive biomarker for response
CCTG BR31 A phase III prospective double blind randomized study of adjuvant MEDI4736 in completeley resected non-small cell lung cancer NCIC CTG protocol number: BR.31
Breast Cancer CommitteeBR15-10 Lancet Oncol. 2019 Dec;20(12):1750-1759. PMID : 31668850 Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial.
BR11-06 Br J Cancer. 2019 Dec;121(12):985-990. PMID : 31690831 Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)
Int J Cancer. 2019 Sep 15;145(6):1669-1678. PMID : 30720867 Molecular alterations and poziotinib efficacy, a pan-HER inhibitor, in human epidermal growth factor receptor 2 (HER2)-positive breast cancers: Combined exploratory biomarker analysis from a phase II clinical trial of poziotinib for refractory HER2-positive breast cancer patients
BR13-11 Breast Cancer Res Treat. 2019 Nov;178(2):367-377. PMID : 31407230 Exploratory biomarker analysis from a phase II clinical trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine for HER2-negative metastatic breast cancer patients (KCSG BR13-11).
BR11-01 Cancer Res Treat. 2019 Jan;51(1):43-52. PMID : 29458237 Randomized Open Label Phase III Trial of Irinotecan Plus Capecitabine versus Capecitabine Monotherapy in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane: PROCEED Trial (KCSG BR 11-01).
BR13-11 Cancer Commun (Lond). 2019 May 28;39(1):29. PMID : 31138332 Quality of life outcomes including neuropathy-associated scale from a phase II, multicenter, randomized trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy for HER2-negative metastatic breast cancer: Korean Cancer Study Group Trial (KCSG BR13-11).
Colorectal Cancer Committee
CO17-07 Cancer Res Treat. 2020 Apr 24. PMID : 32340084 A Phase II Study of Avelumab Monotherapy in Patients with Mismatch Repair-Deficient/Microsatellite Instability-High or POLE-Mutated Metastatic or Unresectable Colorectal Cancer
CO12-04 Korean J Intern Med. 2019 Jan;34(1):165-177. PMID : 29172407 The impact of primary tumor location in patients with metastatic colorectal cancer: a Korean Cancer Study Group CO12-04 study
GU&GY Cancer Committee GU10-16 Eur J Cancer. 2020 Mar;127:183-190. PMID : 31668839 Gemcitabine plus carboplatin versus gemcitabine plus oxaliplatin in cisplatin-unfit patients with advanced urothelial carcinoma: a randomised phase II study (COACH, KCSG GU10-16).
GU17-03 Cancer Med. 2019 Sep;8(12):5431-5437. PMID : 31353788
Comparative effectiveness of palliative chemotherapy versus neoadjuvant chemotherapy followed by radical cystectomy versus cystectomy followed by adjuvant chemotherapy versus cystectomy for regional node-positive bladder cancer: A retrospective analysis: KCSG GU 17-03
GU11-03 Cancer Res Treat. 2019 Oct;51(4):1578-1588. PMID : 30999721 Temsirolimus in Asian Metastatic/Recurrent Non-clear Cell Renal Carcinoma
Hepatobiliary & Pancreatic Cancer Committee Ther Adv Med Oncol. 2019 Aug 23;11:1-9 PMID : 31489036 Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group.
Lung Cancer Committee LU15-09 J Clin Oncol. 2020 Feb 10;38(5):488-495. PMID : 31825714 Osimertinib for Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09) LU12-13 Cancer Res Treat. 2019 Apr;51(2):718-726. PMID : 30177585 A Randomized, Open-Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed versus Pemetrexed Alone in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer after Failure of First-Line EGFR Tyrosine Kinase Inhibitor: KCSG-LU12-13
Palliative Care Committee PC13-09 Oncologist. 2020 Mar;25(3):e502-e511. PMID : 32162799 Polypharmacy, Inappropriate Medication Use, and Drug Interactions in Older Korean Patients with Cancer Receiving First-Line Palliative Chemotherapy
PC14-17 Support Care Cancer. 2020 Nov;28(11):5177-5183. PMID : 32056013 Interference with daily functioning by breakthrough pain in patients with cancer
PC17-01 Cancer Res Treat. 2019 Oct;51(4):1632-1638. PMID : 30999720 Feasibility Study of Physician Orders for Life-Sustaining Treatment for Patients with Terminal Cancer
PC13-09 J Geriatr Oncol. 2019 Sep;10(5):749-756. PMID : 30952517 Serum biomarkers for predicting overall survival and early mortality in older patients with metastatic solid tumors
Stomach Cancer Committee ST10-01 Oncologist. 2019 Jan;24(1):18-e24. PMID : 30126861 A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01)
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