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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031317
Receipt No. R000035746
Scientific Title Phase II study of TAS-102 plus bevacizumab as maintenance therapy after induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine in patients with metastatic colorectal cancer
Date of disclosure of the study information 2018/02/16
Last modified on 2018/02/15

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Basic information
Public title Phase II study of TAS-102 plus bevacizumab as maintenance therapy after induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine in patients with metastatic colorectal cancer
Acronym Switch Maintenance Study
Scientific Title Phase II study of TAS-102 plus bevacizumab as maintenance therapy after induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine in patients with metastatic colorectal cancer
Scientific Title:Acronym Switch Maintenance Study
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We conduct a first line induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine in patients with metastatic colorectal cancer. Induction therapy will be stop systematically for 3 to 4 months then; the chemotherapy switch to TAS-102 plus bevacizumab. Aim of this study is to evaluate efficiency and safety of TAS-102 plus bevacizumab as maintenance therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival, Response rate, Disease control rate, Rechallenge rate of oxaliplatin, Safety; periods of maintenance therapy, dose intensity, adverse event, total dose of oxaliplatin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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
TAS-102 35 mg/time, twice a day, oral intake Day1-5,8-12
Bevacizumab venous injection, 5.0 mg/kg Day1,15

Patients will continue study treatment until disease progression
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) Historical or cytological documentation of adenocarcinoma of the colon or rectum
2) First line chemotherapy and non-resectable advanced colorectal cancer. If patients were performed adjuvant chemotherapy, the period until first line chemotherapy has to be at least 6 months.
3) Male or female patients >= 20
4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
5) Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements conducted within 14 days of starting study treatment:
1. Absolute neutrophil count >= 1500 /mm3
2. Hemoglobin >= 9.0 g/dl
3. Platelet >=100000 /mm3
4. Total bilirubin <=1.5 ml/dl
5. AST and ALT <=100 IU/l
6. Creatinine <= 1.5 mg/dl
6) Life expectancy of at least 90 days.
7) Patients must have measurable or non measurable disease according to RECIST version 1.1
8) Induction chemotherapy was done by CapeOX+Bevacizumb or FOLFOX+Bevacizumab. Except the induction therapy done by other approved standard therapies which include irinotecan or anti-EGFR drug.
9) Conduct a first line induction chemotherapy with bevacizumab, oxaliplatin, and fluoropyrimidine. Induction therapy will be stop systematically for 3 to 4 months then; the chemotherapy switch to TAS-102 plus bevacizumab; expected oxaliplatin dose is 610 to 680 mg/M2.
10) Confirmed the disease control; CR/PR/SD by each image after induction therapy.
11) Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent.
Key exclusion criteria 1) Prior treatment with TAS-102 and Bevacizumab.
2) Previous or concurrent cancer that is distinct in primary site or histology form colorectal cancer within 1 years prior to EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta, Tis and T1].
3) Major surgical procedure within 28 days before start of study medication.
4) Pregnant or breast-feeding patients. Woman of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
5)Congestive heart failure >=NYHA class 2.
6) Unstable angina, new-onset angina. Myocardial infarction less than 6 months before start of study medication.
7)Uncontrolled hypertension.
8) Pleural effusion or ascites with dyspnea higher than CTCAE v4.0 grade 2.
9) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
10) Known history of HIV infection, or chronic hepatitis B or C.
11) Symptomatic metastatic brain or meningeal metastasis.
12) Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE v4.0 Grade 3 within 4 weeks of start of study medication.
13) Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
14) Persistant proteinuria of CTCAE v4.0 Grade 3 or higher.
15) Patients unable to swallow oral medications.
16) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
17) Non-healing wound, ulcer, or bone fracture.
18) Unsolved toxicity higher than CTCAE v4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity <= Grade 2.
19) A responsible doctor has confirmed the candidate should be excluded from this study.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Ohta
Organization Higashiosaka city medical center
Division name Department of Gastroenterological surgery
Zip code
Address Nishiiwata 3-4-5, Higashiosaka city, Osaka, Japan
TEL 06-6781-5101
Email ohta-k@higashiosaka-hosp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Ohta
Organization Higashiosaka city medical center
Division name Department of Gastroenterological surgery
Zip code
Address Nishiiwata 3-4-5, Higashiosaka city, Osaka, Japan
TEL 06-6781-5101
Homepage URL
Email ohta-k@higashiosaka-hosp.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization Non
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
2018 Year 02 Month 16 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 15 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035746

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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