UMIN-CTR Clinical Trial

Basic information
Public title	TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer
Acronym	SOAC1701
Scientific Title	TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer
Scientific Title:Acronym	SOAC1701
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the safety and efficacy of combination TAS-102 plus Bevacizumab therapy in patients with advanced/recurrent colorectal cancer who was not appropriate for intensive therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	1)Overall Survival 2)Time to Treatment Failure 3)Response Rate 4)Disease control rate 5)Adverse events 6)Relation between RAS status and effectiveness of chemotherapy 7)Relation between location of tumor and effectiveness of chemotherapy 8)Relation between the timing when chemotherapy started and effectiveness of chemotherapy

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patient with any of the fllowing (1) patient who is 20 years or older, and considered to be intorelant to irinotecan or oxaliplatin. (2) Patient who is 20 to 74 years old and with an ECOG Performance Status of 2 (3) Patient who is over 75 years old and with an ECOG Performance Status of 0 or 1 2) patient who has histologically or cytologically confirmed colorectal adenocarcinoma 3) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s) 4) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them 5) patient who has at least one measurable lesion in imaging study 6) patient with ability to tolerate oral drug administration 7) patient who has adequate main organ functions in tests within 14 days before enrollment (1) WBC >= 3500/mm3 (2) neutrophil count >=1,500/mm3 (3) platelet count >=75,000/mm3 (4) haemoglobin concentorarion >=9.0 g/dL (5) AST, ALT <= 2.5x Upper limit of normal (<= 5.0x when liver metastasis exists) (6) serum total bilirubin level <=1.5 mg/dL (<= 2.0 when liver metastasis exists) (7) serum creatinine <=1.5 mg/dL (8) no active infection (9) Peripheral neuropathy<=grade2 (10) Diarrhea and NonHaematotoxicity =<grade1 8) gave written informed consent
Key exclusion criteria	1) contraindications for TAS-102 and BEvacizumab 2) previously received chemotherapy with TAS-102 3) severe drug allergy 4) pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5) patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 6) have pleural effusion and ascitic fluid with the treatment 7) previous hemoptysis (over 25ml of fresh blood) 8) current or previous (within the last 6 months) history of GI perforation 9) patient with thrombosis (within the last 6 months) 10) patient with bleeding tendency 11) synchronous or metachronous multiple malignancy within the last 5 year disease free interval 12) dicision of unsuitable for this study by the investigator
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Hisahiro Middle name Last name Matsubara
Organization	Chiba University
Division name	Department of frontier surgery
Zip code	260-8677
Address	1-8-1 Inohana, chuo-ku, Chiba-shi, Chiba, JAPAN
TEL	043-226-2109
Email	matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Miyauchi
Organization	Chiba University
Division name	Department of frontier surgery
Zip code	260-8677
Address	1-8-1 Inohana, chuo-ku, Chiba-shi, Chiba, JAPAN
TEL	043-226-2109
Homepage URL
Email	komatsuaki@office.chiba-u.jp

Sponsor
Institute	Surgical Oncology Association in Chiba (SOAC)
Institute
Department

Funding Source
Organization	Department of frontier surgery, Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	CRB
Address	1-8-1 Inohana, chuo-ku, Chiba-shi, Chiba, JAPAN
Tel	043-222-7171
Email	shiken@office.chiba-u.jp

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	2018 Year 03 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	Terminated
Date of protocol fixation	2018 Year 02 Month 19 Day
Date of IRB	2019 Year 01 Month 23 Day
Anticipated trial start date	2019 Year 03 Month 20 Day
Last follow-up date	2022 Year 03 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 19 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036278