UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).
Title of the study (Brief title)	Phase II study of 3rd-line therapy with S-1 plus cetuximab in patients with KRAS wild type unresectable colorectal cancer(KSCC0901).
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Medicine in general Gastroenterology Hematology and clinical oncology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of S-1 plus cetuximab combination therapy in patients with EGFR positive KRAS wild type unreseactable advanced/reccurent colorectal cancer, who had documented PD of 5FU based chemotherapy, and had received irinotecan and oxaliplatin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival(PFS)
Key secondary outcomes	ORR, OS, OS from first diagnosis, DCR, TTF, DI, safety, BRAF mutation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Cetuximab/S-1 combination therapy Cetuximab weekly administration 400 mg/m2(day1), 250mg/m2/week(except day1) S-1 80-120mg/day, PO from day1 to day 28 of each 42 day cycle.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Written informed consent 2) Patients who is judged by investigator to be able to receive the protocol therapy 3) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced/recurrent colorectal cancer 4) Presence of measurable lesion judged by enhanced CT (according to the RECIST 1.1) 5) Patients who had previously received on irinotecan, oxaliplatin and fluoropyrimidine. 6) Patients who had documented PD of 5FU based chemotherapy. 7) EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity 8) KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed by KSCC central test. 9) Prior chemotherapy was done in the first study treatment before at least 2 weeks 10) Age 20 years<= 11) ECOG performance status 0-1 12) Life expectancy of 3 months 13) Patiens have enough organ function based on blood test within 1 week before registration. 1.WBC>=3,000/mm3 , 2.Neurtophils>=1,500/mm3 3. Platelets>=100,000/mm3 4. Hemoglobin>=9.0g/dl 5. Total bilirubin<=2.0mg/dl 6. AST<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 7.ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) 8. Creatinine<=1.5mg/dl 9. creatinine clearance>=50ml/min
Key exclusion criteria	1) Severe bone marrow suppression 2) Severe infectious disease 3) Massive pleural effusion or ascites 4) Comorbidity or history of severe heart failure 5) Comorbidity or history of interstitial lung disease or pulmonary fibrosis 6) Paralytic or mechanical bowel obstruction 7) Jaundice 8)History of severe allergy 9)Impossible to evaluate disease by enhanced CT 10)Pregnant or lactating women or women of childbearing potential 11)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) 12)Symptomatic brain metastasis 13)Simultaneous or metachronous double cancers 14)Patients who had received anti EGFR drug that include cetuximab. 15)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size	39

Research contact person
Name of lead principal investigator	Shoji Natsugoe
Organization	Kagoshima University Graduate School
Division name	Dept. Surgical Oncology
Address	8-35-1 Sakuragaoka, Kagoshima 890-8520
TEL	099-275-5361
Email	kscc2@cres-kyushu.or.jp

Public contact
Name of contact person	KSCC
Organization	Clinical Research Support Center Kyushu
Division name	KSCC
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL	092-631-2920
Homepage URL
Email	kscc2@cres-kyushu.or.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

九州大学（福岡県）国立病院機構九州医療ｾﾝﾀｰ（福岡県）九州中央病院（福岡県）済生会福岡総合病院（福岡県）済生会八幡総合病院（福岡県）新日鐵八幡記念病院（福岡県）国立病院機構福岡東医療ｾﾝﾀｰ（福岡県）田川病院（福岡県）仲原病院（福岡県）久留米大学（福岡県）久留米大学医療ｾﾝﾀｰ（福岡県）久留米第一病院（福岡県）聖マリア病院（福岡県）公立八女総合病院（福岡県）大牟田市立総合病院（福岡県）済生会唐津病院（佐賀県）健康保険諫早総合病院（長崎県）佐世保市立総合病院（長崎県）佐世保中央病院（長崎県）長崎大学（長崎県）光晴会病院（長崎県）柿添病院（長崎県）済生会熊本病院（熊本県）熊本大学（熊本県）健康保険人吉総合病院（熊本県）大分県立病院（大分県）大分赤十字病院（大分県）国立病院機構大分医療ｾﾝﾀｰ（大分県）国立病院機構別府医療ｾﾝﾀｰ（大分県）大分大学（大分県）中津市立中津市民病院（大分県）小林市立病院（宮崎県）宮崎県立延岡病院（宮崎県）宮崎江南病院（宮崎県）宮崎県立日南病院（宮崎県）国立病院機構南九州病院（鹿児島県）今給黎総合病院（鹿児島県）潤愛会鮫島病院（鹿児島県）鹿児島大学（鹿児島県）鹿児島厚生連病院（鹿児島県）鹿児島共済会南風病院（鹿児島県）慈愛会今村病院（鹿児島県）済生会川内病院（鹿児島県）出水郡医師会立阿久根市民病院（鹿児島県）県民健康ﾌﾟﾗｻﾞ鹿屋医療ｾﾝﾀｰ（鹿児島県）鹿児島県立薩南病院（鹿児島県）浦添総合病院（沖縄県）中頭病院（沖縄県）琉球大学（沖縄県）広島赤十字原爆病院（広島県）松山赤十字病院（愛媛県）有田共立病院（佐賀県）麻生飯塚病院（福岡県）宗像医師会病院（福岡県）熊本市立熊本市民病院（熊本県）国立病院機構都城病院（宮崎県）高野会高野病院（熊本県）天草地域医療ｾﾝﾀｰ（熊本県）福岡市民病院（福岡県）福岡新水巻病院（福岡県）防府消化器病ｾﾝﾀｰ防府胃腸病院（山口県）北九州総合病院（福岡県）岐阜大学病院（岐阜県）箕面市立病院（大阪府）川崎医科大学（岡山県）高地医療ｾﾝﾀｰ（高知県）関西医科大学（大阪府）徳島大学病院（徳島県）岡山大学病院（岡山県）名古屋大学医学部附属病院（愛知県）大阪府立急性期総合医療ｾﾝﾀｰ（大阪府）大阪医療ｾﾝﾀｰ（大阪府）岐阜市民病院（岐阜県）岐阜県総合医療ｾﾝﾀｰ（岐阜県）大阪府立成人病ｾﾝﾀｰ（大阪府）大阪医科大学附属病院（大阪府）健生会土庫病院（奈良県）

Other administrative information
Date of disclosure of the study information	2009 Year 09 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 17 Day
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date	2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 09 Month 10 Day
Last modified on	2016 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003034