Unique ID issued by UMIN | UMIN000018484 |
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Receipt number | R000021400 |
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 |
Date of disclosure of the study information | 2015/08/01 |
Last modified on | 2015/08/05 16:29:55 |
A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy
S-1 and Cetuximab Colon Cancer trial ( SACC trial )
A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy
S-1 and Cetuximab Colon Cancer trial ( SACC trial )
Japan |
advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy
Gastroenterology | Hematology and clinical oncology |
Malignancy
NO
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
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
PFS:Progression Free Survival
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 was administered orally on days 1-14 of a 21-day cycle
cetuximab 400mg/m2 followed by weekly 250mg/m2
65 | years-old | <= |
Not applicable |
Male and Female
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
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.
57
1st name | |
Middle name | |
Last name | TAMOTSU SAGAWA |
NHO HOKKAIDO CANCER CENTER
Division of Gastroenterology
Kikusui4-2, Shiroishi-ku,Sapporo
011-811-9111
tsagawa@sap-cc.go.jp
1st name | |
Middle name | |
Last name | TAMOTSU SAGAWA |
NHO HOKKAIDO CANCER CENTER
Division of Gastroenterology
Kikusui4-2, Shiroishi-ku,Sapporo
011-811-9111
tsagawa@sap-cc.go.jp
NHO HOKKAIDO CANCER CENTER
Division of Gastroenterology
None
Self funding
NO
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
2015 | Year | 08 | Month | 01 | Day |
Unpublished
Open public recruiting
2014 | Year | 10 | Month | 08 | Day |
2015 | Year | 08 | Month | 01 | Day |
2017 | Year | 11 | Month | 30 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 11 | Month | 30 | Day |
2015 | Year | 07 | Month | 30 | Day |
2015 | Year | 08 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021400
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