Unique ID issued by UMIN | UMIN000014892 |
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Receipt number | 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 13:23:29 |
Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation
Phase II study of IRIS+BV followed by SOX+BV in advanced colorectal cancer with RAS mutation
Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation
Phase II study of IRIS+BV followed by SOX+BV in advanced colorectal cancer with RAS mutation
Japan |
Colorectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
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
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Second progression free survival
.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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
SOX+BEV and IRIS+BEV sequential therapy
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
50
1st name | |
Middle name | |
Last name | Kouichi Furukawa |
Department of Gastroenterology & Hepatology, Niigata City General Hospital
Department of Gastroenterology & Hepatology
463-7 Kaneki Chuohku, Niigata, 951-8510 Japan
0252815151
furukawa@hosp.niigata.niigata.jp
1st name | |
Middle name | |
Last name | Yasuo Saijo |
Niigata University Graduate School of Medical and Dental Sciences
Department of Medical Oncology
1-757 Asahimachidori Chuohku, Niigata, 951-8510 Japan
0253689004
yasosj@med.niigata-u.ac.jp
Niigata Colorectal Cancer Study Group
none
Self funding
NO
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
2014 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2014 | Year | 07 | Month | 04 | Day |
2014 | Year | 08 | Month | 01 | Day |
2019 | Year | 06 | Month | 01 | Day |
2014 | Year | 08 | Month | 19 | Day |
2014 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017318
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