UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 trial of TAS-102 plus bevacizumab in patients with advanced/recurrent colorectal cancer who had previously received on oxaliplatin, irinotecan and fluoropyrimidine
Title of the study (Brief title)	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	Kenji Katsumata
Organization	Tokyo Medical University
Division name	Department of Gastrointestinal and Pediatric Surgery
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	Tetsuo Ishizaki
Organization	Tokyo Medical University
Division name	Department of Gastrointestinal and Pediatric Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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