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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026043
Receipt No. 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

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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
Email 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
Email wbc15000@yahoo.co.jp

Sponsor
Institute Tokyo Medical University
Department of Gastrointestinal and Pediatric Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029919

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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