UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy
Acronym	S-1 and Cetuximab Colon Cancer trial ( SACC trial )
Scientific Title	A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy
Scientific Title:Acronym	S-1 and Cetuximab Colon Cancer trial ( SACC trial )
Region	Japan

Condition
Condition	advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the Efficacy and safety of S-1 plus cetuximab in advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	PFS:Progression Free Survival
Key secondary outcomes	Safety ORR:Overall Response Rate OS:Overall Survival ETS:Early Tumor Shrinkage DpR:Deepness of Response RDI:Relative Dose Intensity TTP:Time to progression TTF:Time to treatment failure

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	S-1 was administered orally on days 1-14 of a 21-day cycle cetuximab 400mg/m2 followed by weekly 250mg/m2
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed colorectal cancer. 2) unresectable primary lesion/distant metastasis/lymph node metastasis. In the case of recurrence, no treatment for the first recurrence leision after operation. 3) RAS wild-type. 4) Inappropriate for FOLFIRI, FOLFOX 5) Measurable leision by RECIST.(Ver.1.1) 6) No past history of chemotherapy 7) No past history of radiation therapy 8) Age; more than 65 years old. Life expectancy of more than 3 months. 9) ECOG Performance status 0-2. 10) Patiens have enough organ function for study treatment within 14 days before enrollment; 1 Hb>=9.0g/dL 2 WBC>=3,000/mm3, <12,000/mm3. 3 Neu>=1,500/mm3. 4 PLT>=10.0x104/mm3. 5 Total Bilirubin<=1.5mg/dL. 6 AST/ALT<=100 7 Creatinine<=1.2mg/dL. 8 Creatinine clearance estimation >=50mL/min 11) Oral intake is possible 12) Normal cardiac function confirmed by cardiac electro gram within 28 days of registration 13) Written informed consent
Key exclusion criteria	1) History of severe allergy 2) Active synchronous or metachronous malignancy 3) Severe infectious disease 4) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 5) Massive pleural effusion or ascites 6) Wattery diarrhea 7) Prior treatment of cetuximab or L-OHP or TS-1 8) Patients who is receiving Flucytosine 9) Symptomatic brain metastasis 10) Pregnant or lactating women or women of childbearing potential 11) Severe mental disorders 12) Systemic administration of steroid 13) Severe renal failure, or urinary protein (more than 2+). 14) Prior radiotherapy for primary and metastases leision. 15) History of allergy for L-OHP and other platinating agent 16) Sensory alteration or paresthesia interfering with function. 17) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size	57

Research contact person
Name of lead principal investigator	1st name Middle name Last name TAMOTSU SAGAWA
Organization	NHO HOKKAIDO CANCER CENTER
Division name	Division of Gastroenterology
Zip code
Address	Kikusui4-2, Shiroishi-ku,Sapporo
TEL	011-811-9111
Email	tsagawa@sap-cc.go.jp

Public contact
Name of contact person	1st name Middle name Last name TAMOTSU SAGAWA
Organization	NHO HOKKAIDO CANCER CENTER
Division name	Division of Gastroenterology
Zip code
Address	Kikusui4-2, Shiroishi-ku,Sapporo
TEL	011-811-9111
Homepage URL
Email	tsagawa@sap-cc.go.jp

Sponsor
Institute	NHO HOKKAIDO CANCER CENTER Division of Gastroenterology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	札幌医科大学医学部附属病院 徳島大学病院 国立病院機構 北海道がんセンター 斗南病院 東札幌病院 清田病院 王子総合病院 小樽エキサイ会病院 千歳市立病院 留萌市立総合病院 伊達赤十字病院 函館赤十字病院 製鉄記念室蘭病院 札幌共立五輪橋病院

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry	2018 Year 11 Month 30 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 07 Month 30 Day
Last modified on	2015 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021400

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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