UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002475
Receipt No. R000003034
Scientific Title Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).
Date of disclosure of the study information 2009/09/11
Last modified on 2016/09/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).
Acronym Phase II study of 3rd-line therapy with S-1 plus cetuximab in patients with KRAS wild type unresectable colorectal cancer(KSCC0901).
Scientific Title Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).
Scientific Title:Acronym Phase II study of 3rd-line therapy with S-1 plus cetuximab in patients with KRAS wild type unresectable colorectal cancer(KSCC0901).
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of S-1 plus cetuximab combination therapy in patients with EGFR positive KRAS wild type unreseactable advanced/reccurent colorectal cancer, who had documented PD of 5FU based chemotherapy, and had received irinotecan and oxaliplatin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival(PFS)
Key secondary outcomes ORR, OS, OS from first diagnosis, DCR, TTF, DI, safety, BRAF mutation

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 Cetuximab/S-1 combination therapy
Cetuximab weekly administration 400 mg/m2(day1), 250mg/m2/week(except day1)
S-1 80-120mg/day, PO from day1 to day 28 of each 42 day cycle.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Written informed consent
2) Patients who is judged by investigator to be able to receive the protocol therapy
3) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced/recurrent colorectal cancer
4) Presence of measurable lesion judged by enhanced CT (according to the RECIST 1.1)
5) Patients who had previously received on irinotecan, oxaliplatin and fluoropyrimidine.
6) Patients who had documented PD of 5FU based chemotherapy.
7) EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity
8) KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed by KSCC central test.
9) Prior chemotherapy was done in the first study treatment before at least 2 weeks
10) Age 20 years<=
11) ECOG performance status 0-1
12) Life expectancy of 3 months
13) Patiens have enough organ function based on blood test within 1 week before registration.

1.WBC>=3,000/mm3 , 2.Neurtophils>=1,500/mm3
3. Platelets>=100,000/mm3
4. Hemoglobin>=9.0g/dl
5. Total bilirubin<=2.0mg/dl
6. AST<=upper limit of normal (ULN)*2.5
(<=ULN*5 in case of liver metastasis)
7.ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis)
8. Creatinine<=1.5mg/dl
9. creatinine clearance>=50ml/min
Key exclusion criteria 1) Severe bone marrow suppression
2) Severe infectious disease
3) Massive pleural effusion or ascites
4) Comorbidity or history of severe heart failure
5) Comorbidity or history of interstitial lung disease or pulmonary fibrosis
6) Paralytic or mechanical bowel obstruction
7) Jaundice
8)History of severe allergy
9)Impossible to evaluate disease by enhanced CT
10)Pregnant or lactating women or women of childbearing potential
11)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc)
12)Symptomatic brain metastasis
13)Simultaneous or metachronous double cancers
14)Patients who had received anti EGFR drug that include cetuximab.
15)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Natsugoe
Organization Kagoshima University Graduate School
Division name Dept. Surgical Oncology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520
TEL 099-275-5361
Email kscc2@cres-kyushu.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name KSCC
Organization Clinical Research Support Center Kyushu
Division name KSCC
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL 092-631-2920
Homepage URL
Email kscc2@cres-kyushu.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
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 九州大学(福岡県)国立病院機構九州医療センター(福岡県)九州中央病院(福岡県)済生会福岡総合病院(福岡県)済生会八幡総合病院(福岡県)新日鐵八幡記念病院(福岡県)国立病院機構福岡東医療センター(福岡県)田川病院(福岡県)仲原病院(福岡県)久留米大学(福岡県)久留米大学医療センター(福岡県)久留米第一病院(福岡県)聖マリア病院(福岡県)公立八女総合病院(福岡県)大牟田市立総合病院(福岡県)済生会唐津病院(佐賀県)健康保険諫早総合病院(長崎県)佐世保市立総合病院(長崎県)佐世保中央病院(長崎県)長崎大学(長崎県)光晴会病院(長崎県)柿添病院(長崎県)済生会熊本病院(熊本県)熊本大学(熊本県)健康保険人吉総合病院(熊本県)大分県立病院(大分県)大分赤十字病院(大分県)国立病院機構大分医療センター(大分県)国立病院機構別府医療センター(大分県)大分大学(大分県)中津市立中津市民病院(大分県)小林市立病院(宮崎県)宮崎県立延岡病院(宮崎県)宮崎江南病院(宮崎県)宮崎県立日南病院(宮崎県)国立病院機構南九州病院(鹿児島県)今給黎総合病院(鹿児島県)潤愛会鮫島病院(鹿児島県)鹿児島大学(鹿児島県)鹿児島厚生連病院(鹿児島県)鹿児島共済会南風病院(鹿児島県)慈愛会今村病院(鹿児島県)済生会川内病院(鹿児島県)出水郡医師会立阿久根市民病院(鹿児島県)県民健康プラザ鹿屋医療センター(鹿児島県)鹿児島県立薩南病院(鹿児島県)浦添総合病院(沖縄県)中頭病院(沖縄県)琉球大学(沖縄県)広島赤十字原爆病院(広島県)松山赤十字病院(愛媛県)有田共立病院(佐賀県)麻生飯塚病院(福岡県)宗像医師会病院(福岡県)熊本市立熊本市民病院(熊本県)国立病院機構都城病院(宮崎県)高野会高野病院(熊本県)天草地域医療センター(熊本県)福岡市民病院(福岡県)福岡新水巻病院(福岡県)防府消化器病センター防府胃腸病院(山口県)北九州総合病院(福岡県)岐阜大学病院(岐阜県)箕面市立病院(大阪府)川崎医科大学(岡山県)高地医療センター(高知県)関西医科大学(大阪府)徳島大学病院(徳島県)岡山大学病院(岡山県)名古屋大学医学部附属病院(愛知県)大阪府立急性期総合医療センター(大阪府)大阪医療センター(大阪府)岐阜市民病院(岐阜県)岐阜県総合医療センター(岐阜県)大阪府立成人病センター(大阪府)大阪医科大学附属病院(大阪府)健生会土庫病院(奈良県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 10 Day
Last modified on
2016 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.