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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030077
Receipt No. R000034327
Scientific Title Phase II study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy
Date of disclosure of the study information 2018/01/09
Last modified on 2018/09/20

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Basic information
Public title Phase II study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy
Acronym PhaseII study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy (JFMC51-1702-C7)
Scientific Title Phase II study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy
Scientific Title:Acronym PhaseII study investigating efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy (JFMC51-1702-C7)
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of TFTD plus bevacizumab by RAS mutation status in patients with unresectable advanced or recurrent colorectal cancer refractory or intolerant to standard chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate (DCR) by RAS mutation status
Key secondary outcomes DCR in full analysis set
Progression-free survival
Overall survival
Objective response rate
Safety
Efficacy and safety by the BRAF mutation status (exploratory outcome)

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 No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TFTD: 35 mg/m. given orally twice daily on days 1-5 and 8-12 in a 28-day cycle
Bevacizumab: 5 mg/kg,
administered by intravenous infusion for 30 min every 2 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed advanced or recurrent colorectal adenocarcinoma (exclude appendix and anal cancer)
2.Unresectable colorectal cancer confirmed by imaging
3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4.Confirmed RAS mutation status
5.Treatment history of one or more regimens of standard chemotherapy
(1) Refractory or intolerant to fluoro
pyrimidine, irinotecan, oxaliplatin, angiogenesis inhibitor (bevacizumab, ramucirumab, or aflibercept), and anti-EGFR antibody (cetuximab or panitumumab) for wild-type RAS
(2) Exclude history of intolerance to bevacizumab
(3)Include history of adjuvant chemotherapy if a tumor had relapsed within 6 months after the last administration
6 No treatment history of regorafenib and TFTD
7.Measurable lesions based on the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) within the 21 days before enrolment
8.Adequate bone marrow,hepatic,and renal functions
9.Written informed consent
Key exclusion criteria 1.History of intolerance to bevacizumab
2.Thromboembolic events within the 6 months before enrolment
3.Active bleeding
4.Severe heart disease within the 6 months before enrolment
5.Cerebrovascular events
6.Active infections
7.Ascites, pleural effusion, or pericardial effusion requiring treatment
8.Gastrointestinal obstruction, renal failure, or liver failure
9.Uncontrolled diabetes mellitus
10.Uncontrolled hypertension
11.Positive for Hepatitis B surface antigen (HbsAg+) or Hepatitis C antibody (HCV Ab+)
12.Other active cancer
13.Symptomatic brain metastases
14.Requiring immunosuppressive treatment due to an autoimmune disorder or history of organ transplantation
15.Treatment history;
(1)Major surgery (i.e., thoracotomy or laparotomy) within the 4 weeks before enrollment
(2)Chemotherapy within the 2 weeks before enrollment
(3)Extensive exposure of radiation within the 4 weeks before enrollment
16.Unresolved adverse events of grade 2 or higher (classified with the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) from previous treatment
17.Unhealed wound or traumatic fracture
18.tendency of haemorrhage and undergoing treatment with an antithrombotic drug (including a daily dose of 325 mg or more of oral aspirin)
19.Females who are in pregnancy, breastfeeding, with a positive pregnancy test or unwilling to use adequate contraception or males of reproductive potential
20.Clinically significant mental or psychological disorder
21.Patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)TAKAO TAKAHASHI 2)KENTARO YAMAZAKI 3)EIJI OKI
Organization 1)Gifu University, Graduate School of Medicine
2)Shizuoka Cancer Center
3)Graduate School of Surgery and Science Kyushu University
Division name 1)Department of Surgical Oncology 2)Division of Gastrointestinal Oncology 3)Department of Surgery and Science
Zip code
Address 1) 1-1 Yanagido, Gifu city, GIFU,501-1194, Japan 2)1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, SHIZUOKA, 411-8777, Japan 3)3-1-1 Maidashi, Higashi-ku, Fukuoka City, FUKUOKA, 812-8585, Japan
TEL 03-5627-7594
Email jfmc51@jfmc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name TAKAO TAKAHASHI
Organization Gifu University, Graduate School of Medicine
Division name Department of Surgical Oncology
Zip code
Address 1-1 Yanagido, Gifu city, GIFU,501-1194, Japan
TEL 03-5627-7594
Homepage URL http://www.jfmc.or.jp/
Email jfmc51@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization TAIHO 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
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 09 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034327

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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