UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030077 |
|---|---|
| Receipt number | 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 | 2021/07/12 14:26:08 |
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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 | 1)TAKAO 2)KENTARO 3)EIJI |
| Middle name | |
| Last name | 1)TAKAHASHI 2)YAMAZAKI 3)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
1)501-1194 2)411-8777 3)812-8582
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
jfmc51@jfmc.or.jp
Public contact
Name of contact person
| 1st name | TAKAO |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Gifu University, Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
501-1194
Address
1-1 Yanagido, Gifu city, GIFU,501-1194, Japan
TEL
03-5627-7594
Homepage URL
http://www.jfmc.or.jp/
jfmc51@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
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
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba
Tel
04-7133-1111
ncche-irb@east.ncc.go.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
| 2018 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.esmoop.2021.100093
Number of participants that the trial has enrolled
102
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
| 2017 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 10 | Day |
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
| 2021 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034327
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