UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023446 |
|---|---|
| Receipt number | R000027015 |
| Scientific Title | A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy (NCCH1503,Lemon trial) |
| Date of disclosure of the study information | 2016/08/02 |
| Last modified on | 2020/01/16 15:14:46 |
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Basic information
Public title
A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy
(NCCH1503,Lemon trial)
Acronym
A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy
(NCCH1503,Lemon trial)
Scientific Title
A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy
(NCCH1503,Lemon trial)
Scientific Title:Acronym
A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy
(NCCH1503,Lemon trial)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of lenvatinib in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapy (fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, TAS-102 and cetuximab or panitumumab in patients with RAS wild-type)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate
Key secondary outcomes
Adverse events
Overall response rate
Progression-free survival
Overall survival
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
24mg of lenvatinib is orally taken once daily.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Pathologically proven colorectal adenocarcinoma
2)Unresectable metastatic colorectal cancer (except for appendiceal and anal canal cancer)
3)Refractory or intolerable to all of the following standard chemotherapy
a.Fluoropyrimidines,oxaliplatin,irinotecan and bevacizumab
b.Cetuximab or panitumumab in patients with RAS wild-type
c.TAS-102
4)No symptomatic brain metastasis and carcinomatous meningitis
5)Oral intake
6)Aged 20 to 79 years
7)Performance Status 0 or 1
8)One or more measurable lesions confirmed by contrast enhanced CT
9)No prior treatment of lenvatinib and regorafenib
10)Not received anti-cancer therapy within 14days before registration
11)Adequately controlled blood pressure
12)Not having any of the following histories/complications
a.History/complication of hypertensive crisis or hypertensive encephalopathy
b.History of total gastrectomy
c.History of surgery under general anesthesia or laparotomy biopsy within 28days before registration
d.Complication of unrecovered wound,active gastrointestinal ulcer or bleeding from the primary lesion
e.Complication of congenital hemorrhagic diathesis or coagulation disorder
f.Complication of cardiovascular diseases requiring more than 325mg of aspirin daily
13)Adequate organ functions defined as below within 14days before registration
a.Neutrophil count >=1500/mm3
b.Platelet count >=100000/mm3
c.Hemoglobin >=8.5g/dL
d.Total bilirubin <=1.8mg/dL
e.AST(GOT)<=100U/L (<=150U/L with liver metastases)
f.ALT(GPT)<=100U/L (<=150U/L with liver metastases)
g.Creatinine <=1.5mg/dL
h.PT-INR <=1.5(<=3.0 in patients receiving any prophylactic anticoagulant agents)
i.Adequate proteinuria value defined
i)Negative to 1+ on urine dipstick testing
ii)When >2+ on urine dipstick testing, <=1g/24hr by 24hr urine collection
14)Given consent to contraception
15)Written informed consent
Key exclusion criteria
1)Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible
2)Infections requiring systemic therapy
3)Fever of >=38 degrees Celsius at the time of registration
4)Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia and grade 2 peripheral neurotoxicity
5)Pregnant or breast-feeding women,or women suspected of being pregnant
6)Mental disease interfering taking part in the trial
7)Taking continuous systemic steroids and/or other immunosuppressive drugs(orally or intravenously)
8)HIV antibody positive
9)Interstitial pneumonia and/or pulmonary fibrosis and/or severe pulmonary emphysema diagnosed by chest CT imaging
10)History of any of the followings; unstable angina and transient ischemic attacks within 6 months before registration, or heart attack,pulmonary embolism,deep vein thrombosis,brain bleeding,cerebral infarction and arterial thromboembolism
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Iwasa |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
siwasa@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamiko Kawasaki |
Organization
National Cancer Center Hospital
Division name
Clinical Trial Support Office
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
makawasa@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Center for Clinical Trials,
Japan Medical Association
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Eisai Co,Ltd.
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 02 | 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
30
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
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2020 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027015
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