UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026043 |
|---|---|
| Receipt number | R000029919 |
| Scientific Title | Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2017/02/08 08:16:05 |
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Basic information
Public title
Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine
Acronym
Phase 2 trial of TAS-102 with bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on standard therapies
Scientific Title
Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine
Scientific Title:Acronym
Phase 2 trial of TAS-102 with bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on standard therapies
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination TAS-102 plus Bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate
Key secondary outcomes
Progression free survival
Overall survival
frequency and grade of adverse events
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(35mg/m2) is administered orally twice daily in 1-5days and 15-20 days and Bevacizumab(5mg/kg) is administered by injection in day 1 and day15. 1 cycle is 28days.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven adenocarcinoma of colon or rectum
2) 20-80 years old
3) Previously received at least
one prior regimens of standard chemotherapies including oxaliplatin, irinotecan and fluoropyrimidine
4) ECOG performance status of 0 or 1
5) At least one measurable lesion (RECIST 1.1)
6) Adequate organ function:
1.Leukocytes: 3,000-12,000/mm3
2.Neutrophil: >= 1,500/mm3
3.Platelets: >= 100,000/mm3
4.Serum total bilirubin: <= 1.5mg/dL
5.Serum AST, ALT: <= 100U/L (or 200U/L in cases after biliary drainage), ALT <= 100U/L (or 150U/L in cases liver metastasis)
6.Serum creatinine: <= 1.2mg/dL
7) Adequate oral intake
8) Life expectancy of 3 months
9) Written informed consent
Key exclusion criteria
1) Previously received TAS-102 or regorafenib
2) Serious drug allergy (excluding oxaliplatin)
3) Serious myelosuppression
4) Active infectious disease
5) Interstitial lung disease or pulmonary fibrosis
6) Watery diarrhea
7) Serious comorbid illness (intestinal paralysis, obstruction, uncontrolled diabetes, renal failure, liver failure, etc)
8) Other active malignancies
9) Pregnancy, breast feeding, or women who desire to preserve fecundity. Men who want his partner to be pregnant
10) Patients who were judged inappropriate for the entry to this study by the investigators
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Katsumata |
Organization
Tokyo Medical University
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
6-7-1,Nishishinjuku,Shinjuku- ku,Tokyo,160-0023
TEL
03-3342-6111
k-katsu@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Ishizaki |
Organization
Tokyo Medical University
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
6-7-1,Nishishinjuku,Shinjuku- ku,Tokyo,160-0023
TEL
03-3342-6111
Homepage URL
wbc15000@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University
Department of Gastrointestinal and Pediatric Surgery
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical 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
東京医科大学 消化器・小児外科学分野（東京都）
東京医科大学八王子医療センター（東京都）
戸田中央総合病院（埼玉県）
厚生中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029919
