UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022535 |
|---|---|
| Receipt number | 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 23:15:49 |
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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
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
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025919
