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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022535
Receipt No. R000025919
Scientific Title A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
Date of disclosure of the study information 2016/05/31
Last modified on 2018/01/25

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Basic information
Public title A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
Acronym A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
Scientific Title A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
Scientific Title:Acronym A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
Region
Japan

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

Objectives
Narrative objectives1 A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering OPTIMOX.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PFS: Progression-free survival
Key secondary outcomes

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 TAS-102+Bevacizumab
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. Patients with unresectable advanced/relapsed colorectal cancer.
2. Aged over 20 at the time of informed consent.
3. ECOG performance status (PS) of 0 to 2
4. Patients with lesion(s) that can be evaluated and it should be confirmed by CT, MRI, X-ray.
5. The cases without a history of chemotherapy but possible to register if over 180 days have been passed since the last day of postoperative adjuvant chemotherapy.
6. Oral intake
7. Major organ functions are maintained by a laboratory study.
8. The cases could survive at least for 3 months from the registration day.
9. IC is obtained in a document from the patients.
Key exclusion criteria 1. The cases with serious drug hypersensitivity or allergy.
2. Pregnant or men who expect the partner's pregnancy.
3. The cases with infectious disease requiring systemic therapy.
4. The cases with serious complications
- Interstitial pneumonia, pulmonary fibrosis
- Heart failure
- Renal failure
- Liver failure
- Poor control diabetes mellitus
- Poor control high blood pressure
5. Cases with ECG abnormalities are found or heart disease as a clinical problem , ( heart failure , myocardial infarction , angina pectoris).
6. Cases with gastrointestinal ulceration or bleeding.
7. Pre-existing with hemoptysis.
8. Cases with peripheral nerve disorder.
9. Patients who need a treatment for abdominal dropsy and pleural effusion.
10. Possibility of brain metastasis.
11. Perforation of the digestive tract within 6 months from the day of registration.
12. Pre-existing with thromboembolism, cerebral infarction, lung infarction and pneumonitis.
13. Surgery within 28 days from the registration day.
14. Bleeding tendency
15. Multiple primary cancers
16. Constitutional administration therapy with steroid
17. The cases judged to be unsuitable for registration.
18. Primary lesion with stricture
19. Cases with peritoneal metastasis
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Tsutsumi
Organization Gunma University Hospital
Division name Integrative Center of General Surgery
Zip code
Address 3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL 027-220-8224
Email chuchumi@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Graduate School of Medicine
Division name Department of Oncology Clinical Development
Zip code
Address 3-39-22 Showa-machi Maebashi Gunma 371-8511
TEL 027-220-8222
Homepage URL
Email kkaira1970@yahoo.co.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 05 Month 31 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
2015 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 01 Month 17 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 30 Day
Last modified on
2018 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025919

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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