UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy
Acronym	A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer
Scientific Title	A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy
Scientific Title:Acronym	A phase II study of TAS-102 plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and toxicity of TAS-102 and bevacizumab for advanced/recurrent colorectal cancer with difficulty on intensive chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Response Rate Disease control rate Overall survival 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 plus bevacizumab combination therapy (q4w) TAS-102: 35mg/m2 BID on days 1-5 and 8-12 Bevacizumab: 5mg/kg on day1 and 15
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) histologically proven colon cancer or rectal cancer (both Kras Wt and MT) 2) Group E : >= 76 years old Group ID : >= 65 years old and with difficulty on intensive chemotherapy due to history of radiation therapy for the pelvic lesions, s-albumin lower than 3.5g/dl and/or doctors decision not to register to the other chemotherapy from intolerance to adverse events 3) with mesurable lesions for RECIST criteria 4) without any chemotherapy berore (eligible if fluoro-pyrimidine treatment has completed more than 6 months before) 5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 6) rest period from former therapy a) more than 4 weeks from an organ resection surgery b) more than 4 weeks from hormone therapy or immune therapy c) more than 4 weeks from cytokine or BRM therapy d) more than 6 weeks from radiation therapy for extensive lesions 7) without any severe complications and limited in the following data a) neutrophile : 1,500/mm3 <= b) platelet : 100,000/mm3 <= c) hemoglobin : 9.0g/dl <= d) T.bil. : 1.5mg/dl >= e) AST, ALT : 100 IU/l ( within 2.5 times of normal range of the hospital f) creatinine : 1.5mg/dl >= g) urine protein : 1+ >= h) PT-INR : 1.5 >= 8) patients expected more than 8 weeks survival 9) able to oral intake 10) written with informed consent
Key exclusion criteria	1) with symptoms due to brain metastatis 2) with uncontrolable diarrhea 3) with difficulty on oral intake due to intestinal paralysis or obstruction 4) with infections diseases or febrile condition 5) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc) 6) with severe diseases (uncontrollable DM, heart failure severe than NYHA lll, renal failure, and/or hepatic failure) 7) pregnant and/or nursing women, or women who expect pregnancy 8) with metastatic meningitis, uncontrollable convulsion, and/or mental disorder 9) with a condition intolerance to medicines in this regimen 10)with a history of some chemotherapy and/or therapy including a VEGF antagonist 11) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction 12) under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 13) with active wounds except reservoir surgery 14) with a history of bloody spit more than 2.5ml 15) with no bowel obstruction 16) with no peritoneum disseimination 17) any other patient whom the physician in charge of the study judges to be unsuitabl
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naotoshi Sugimoto
Organization	Osaka medical Center for Cancer and Cardiovascular Diseases
Division name	Clinical Oncology
Zip code
Address	1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL	06-6972-1181
Email	sugimoto-na2@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Middle name Last name Naotoshi Sugimoto
Organization	Osaka medical Center for Cancer and Cardiovascular Diseases
Division name	Clinical Oncology
Zip code
Address	1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL	06-6972-1181
Homepage URL
Email	sugimoto-na2@mc.pref.osaka.jp

Sponsor
Institute	Osaka medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Osaka medical Center for Cancer and Cardiovascular Diseases
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 06 Month 12 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	2016 Year 03 Month 31 Day
Date of IRB	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 06 Month 13 Day
Last follow-up date	2019 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 12 Day
Last modified on	2019 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025658