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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014892
Receipt No. R000017318
Scientific Title Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation
Date of disclosure of the study information 2014/09/01
Last modified on 2014/08/19

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Basic information
Public title Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation
Acronym Phase II study of IRIS+BV followed by SOX+BV in advanced colorectal cancer with RAS mutation
Scientific Title Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation
Scientific Title:Acronym Phase II study of IRIS+BV followed by SOX+BV in advanced colorectal cancer with RAS mutation

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

Narrative objectives1 To evaluate efficacy and safety of 1st line SOX+BEV and 2nd line IRIS+BEV sequential therapy for unresectable advanced and recurent colorectal cancer with RAS mutation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Primary outcomes Second progression free survival
Key secondary outcomes .Overall survival
.Transfer ratio of 2nd line chemotherapy
.Term of 1st line chemotherapy to 2nd line chemotherapy
Each of the 1st line and 2nd line chemotherapy
.Progression Free Survival: PFS
.Time to treatment failure: TTF
.Relative dose intensity: RDI
.Response Rate

.Frequency and Grade of Adverse Event
.Term of hospitalization and frequency of visiting the hospital
.Biomarker analysis

Study type Interventional

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

No. of arms 1
Purpose of intervention Treatment
Type of intervention
Interventions/Control_1 SOX+BEV and IRIS+BEV sequential therapy

Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologocally or cytologycally proved colorectal cancer(adenocarcinoma)
2)Unresectable advanced or recurrent colorectal cancer
3)RAS mutated type
4)Elder than 20years of age
5)ECOG performance status of 0-1
6)Measureable region evaluable according to the RECIST of Computed Tomography or Magnetic Reasonance Image or X-ray within 30days
7)Previously no chemotherapy and no radiation therapy in case of postoperative adjuvant chemotherapy passed more 180days
8)Possible oral intake
9)Laboratory data within 14days satisfies the following conditions
1.WBC => 3,000 /mm3, WBC=<12,000 /mm3
2.Neutrophil =>1,500 /mm3
3.Platelet => 100,000 /mm3
4.hemoglobin concentration => 9.0 g/dl
5.Total bilirubin <= 2.0 mg/dl
6.AST or ALT <= 100IU/L
7.AST or ALT <= 200IU/L with liver metastasis
8.Ccr>= 60mL/min with an actual measurement in 24hr.
Without measurement to use Cockcroft-Gault Ccr=[(140-age)*body weight]/[72*serum cre](if female 0.85*)
9.Uric protein<=1+
10.INR <=1.5
10)Life expectancy of at least 3months
11)Written informed consent
Key exclusion criteria 1)Presence of severe drug allergy
2)Pregnant patients
3)Active infection(>=38.0C)
4) Presence of severe complication(interstitial pneumonia or lung fibrosis, renal failure, liver failure, Poorly controlled diabetes mellitus poorly controlled hypertension
5) Remarkable ECG change or clinical heart disease (heart failure, AMI, angina)
6) Active gastric bleeding or gastric ulcer
7) Peripheral neuropathy
8) Severe diarrhea
9) Pleural effusion or ascites needed to treat
10) Gastrointestinal perforation in 6 months (without obstractive colorectal cancer)
11) Thromboembolism or cerebral infarction(without asymptomatic lacunar infarction ), pulmonary infraction, intestinal pneumonia
12) Operation within 28days (an exception of implanting central venous reservoir)
13) Congenital hemorrhagic diathesis or coagulopathy
14) Other active malignancies
of DFS is within 5years (except for the case skin basal carcinoma and cervical cancer be cured or Stomach cancer, esophageal cancer, colorectal pM cancer that was confirmed cured by an endoscopic treatment)
15) Needed to dosage systemic steroid
16) Evaluated to be ineligible by a physician for other reasons
17) Hemoptysis( more than 2.5ml)
18) Contraindication of L-OHP ,CPT-11, BV , TS-1
19) Primary tumor with severe stenosis that an endoscope does not pass(Except for the case that constructed excision of the primary tumor or the artificial anus)
20) Peritoneum metastasis confirmed with an image.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi Furukawa
Organization Department of Gastroenterology & Hepatology, Niigata City General Hospital
Division name Department of Gastroenterology & Hepatology
Zip code
Address 463-7 Kaneki Chuohku, Niigata, 951-8510 Japan
TEL 0252815151

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Saijo
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Medical Oncology
Zip code
Address 1-757 Asahimachidori Chuohku, Niigata, 951-8510 Japan
TEL 0253689004
Homepage URL

Institute Niigata Colorectal Cancer Study Group

Funding Source
Organization none
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions 新潟市民病院、新潟大学医歯学総合病院、新潟県立がんセンター新潟病院、長岡中央病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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

Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information

Management information
Registered date
2014 Year 08 Month 19 Day
Last modified on
2014 Year 08 Month 19 Day

Link to view the page

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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