UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018484 |
|---|---|
| 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 |
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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
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
tsagawa@sap-cc.go.jp
Sponsor or person
Institute
NHO HOKKAIDO CANCER CENTER
Division of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021400
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