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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035638
Receipt No. R000040531
Scientific Title A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer
Date of disclosure of the study information 2019/01/23
Last modified on 2019/01/23

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Basic information
Public title A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer
Acronym TFTD plus Bmab for unresectable colorectal cancer
Scientific Title A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer
Scientific Title:Acronym TFTD plus Bmab for unresectable colorectal cancer
Region
Japan

Condition
Condition unresectable advanced colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate time to treatment failure of TFTD plus Bevacizumab therapy for unresectable advanced colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Time to treatment failure
Key secondary outcomes Safety and efficacy

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 TFTD: fixed dose
Bevacizumab: fixed dose
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 Patients who satisfy all the following criteria are enrolled.
1. Unresectable or recurrent colorectal cancer patients confirmed histopathologically as colorectal cancer.
2. It does not have treatment history by TFTD (Lonsurf) and meets one of the following criteria.
5-FU, L-OHP, CPT-11 already treated
5-FU, L-OHP, CPT-11 unacceptable
Cases who cannot performed for strong treatment.
3. Lesions can be confirmed by image examination within 28 days before registration (measurable lesions are not essential)
4. Performance status (ECOG): 0 to 2 cases.
5. Age >=20
6. A case expected more than 3 months from the administration start date.
7. Case where clinical laboratory test values satisfy all of the following conditions (latest inspection value within 14 days before registration)
[Hematology test value]
White blood cell count >= 3,000 / mm 3, and <= 12,000 mm 3
Number of neutrophils >= 1,500 / mm 3
Number of platelets >= 100,000 / mm 3
Hemoglobin >= 8.0 g / dl
[Liver function test value]
AST (GOT), ALT (GPT) <= 100 U / l (200 U / l in cases of liver metastasis) or less
[Renal function test value]
Serum creatinine <= 1.50 mg / dL
8. Patients with test urine or normal urinalysis with proteinuria less than 1+ (24 hours of urine storage when test urine or 2 >= 2 + proteinuria in normal urinalysis, urine protein 1000 mg can participate if it is less than)
9. Patients without blood transfusion within 14 days before registration
10. Patients who has written informed consent.
Key exclusion criteria Patients who conflict with one of the following will not be included in this clinical study.
1. Patients with simultaneous active malignant disease.
2. Patients who had history of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic disorder (thrombosis of the venous port or catheter or superficial venous thrombosis is not considered serious).
3. Patients with serious bleeding disorder, vasculitis, or serious gastrointestinal bleeding within 3 months before acquiring consent.
4. Patients with gastrointestinal perforation and / or history of fistula.
5. Patients with a history of pulmonary hemorrhage (hemoptysis).
6. Despite standard medical management, patients with uncontrollable arterial hypertension.
7. Patients with serious or unrecovered wounds, a history of peptic ulcer or fracture.
8. Patients with bowel obstruction, complication of inflammatory bowel disease or extensive intestinal resection, patients with Crohn's disease, ulcerative colon or chronic diarrhea.
9. Patients with serious drug allergy.
10. Patients with infection with fever over 38.0.
11. Patients with double active cancers which mean synchronous double cancers or metachronous double cancers with a disease-free period within 5 years.
12. Patients with brain metastasis.
13. Patients with severe complications such as the following.
Patients with complications of infection during antibiotic administration.
Patients with complications of treatment or poor control due to continued use of insulin.
Patients of complication of hypertension with poor control.
Patients with myocardial infarction that developed within 6 months.
Patients with unstable angina.
Patients in which liver cirrhosis was complicated.
Patients in which interstitial pneumonia and pulmonary fibrosis are complicated.
14. Pregnant or nursing female.
15. Patient with mental illness.
16. Not appropriate for the study at the physician's assessment.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagano
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Email hnagano@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Suzuki
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Homepage URL
Email nobusuzu@yamaguchi-u.ac.jp

Sponsor
Institute Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2019 Year 01 Month 23 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 26 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
2019 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040531

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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