UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027108
Receipt number R000031053
Scientific Title The optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with anti-EGFR in the first line setting.
Date of disclosure of the study information 2017/06/01
Last modified on 2019/04/30 08:51:55

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Basic information

Public title

The optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with anti-EGFR in the first line setting.

Acronym

The optimal cut off value of KRAS testing

Scientific Title

The optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with anti-EGFR in the first line setting.

Scientific Title:Acronym

The optimal cut off value of KRAS testing

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To determine the optimal cut off value of KRAS testing for the selection of unresectable colorectal cancer patients more likely to benefit from treatment with mFOLFOX6 + Cmab / Pmab therapy in the first line setting.

Basic objectives2

Others

Basic objectives -Others

Progression-free survival is compared in consideration of the percentage of KRAS mutant clones, such as 1-5,5-10,10-25%, determined by Digital PCR.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression-free survival (PFS)

Key secondary outcomes

Overall response rate (ORR)
Disease Control Rate (DCR)
Overall survival (OS)
Safety


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1,Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
2,Age greater than or equal to 20 years at the time of informed consent
3,KRAS wild type (exon2 codon12,13)determined by direct sequencing. RAS mutations in exon 3,4 are excluded.
4,ECOG performance status (PS) of 0-2
5,Written informed consent prior to study-specific screening procedure
6,Life expectancy of at least 90 days
7,Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy
8,Adequate organ function according to following laboratory values obtained within 14 days before enrollment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test)
i. Neutrophil count: > or = 1500/mm3
ii.Platelet count: > or = 10.0 x 104/mm3
iii.Hemoglobin: > or = 9.0 g/dL
iv.Total bilirubin: < or = 1.5 mg/dL
v.AST, ALT: < or =1.5100 IU/L
(< or = 200 IU/I if liver metastases present)
vi.Serum creatinine: < or =1.5 mg/dL





Key exclusion criteria

1) History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
2) With massive pleural effusion or ascites requiring intervention
3) Radiological evidence of brain tumor or brain metastases
4) Active infection including hepatitis
5) Any of the following concurrent diseases:
i. Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus)
ii. Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure)
iii. Interstitial pneumonia or pulmonary fibrosis
iv. Uncontrolled diabetes mellitus
v. Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)
6) Any of the following medical history:
i. Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes
ii. Serious hypersensitivity to any of the study drugs
iii. History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency
7) Previous treatment with irinotecan hydrochloride
8) Current treatment with atazanavir sulfate
9) Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment
10) Pregnant or lactating females, and males and females unwilling to use contraception

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Suzuki

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Surgery

Zip code

330-8503

Address

1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan

TEL

048-647-2111

Email

ksuzbnhm@omiya.jichi.ac.jp


Public contact

Name of contact person

1st name Suzuki
Middle name
Last name Koichi

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Surgery

Zip code

330-8503

Address

1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan

TEL

048-647-2111

Homepage URL


Email

ksuzbnhm@omiya.jichi.ac.jp


Sponsor or person

Institute

Department of Surgery, Jichi Medical University, Saitama Medical Center,
1-847 Amanuma, Saitamacity, Saitama, 330-8503, Japan.

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jichi Medical University, Saitama Medical Center

Address

1-847 Amanuma, Omiya, Saitama 330-8503, Japan.

Tel

048-647-2111

Email

ksuzbnhm@omiya.jichi.ac.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 06 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

Terminated

Date of protocol fixation

2017 Year 04 Month 28 Day

Date of IRB

2017 Year 04 Month 24 Day

Anticipated trial start date

2017 Year 06 Month 01 Day

Last follow-up date

2018 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 04 Month 24 Day

Last modified on

2019 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031053


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name