UMIN-CTR Clinical Trial

Public title

Phase II study of Ccr-based dose-control of S-1 in the first-line chemotherapy of S-1/oxaliplatin(SOX)+bevacizumab regimen for advanced colorectal cancer

Acronym

B-Tune study

Scientific Title

Phase II study of Ccr-based dose-control of S-1 in the first-line chemotherapy of S-1/oxaliplatin(SOX)+bevacizumab regimen for advanced colorectal cancer

Scientific Title:Acronym

B-Tune study

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Ccr-based dose-control of S-1 in the first-line chemotherapy of S-1/oxaliplatin(SOX)+bevacizumab regimen for advanced colorectal cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Adverse events

Key secondary outcomes

OS
PFS
RR
TTF
RDI
R0 resectability
ETS

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ccr-based dose-control of S-1 in the first-line chemotherapy of S-1/oxaliplatin(SOX)+bevacizumab regimen

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with histopathologically confirmed adenocarcinoma.
2. Patients with unresectable recurrent or advanced colorectal cancer.
3. Patients 20 years or older.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
5. unresectable primary tumor or with one or more unresectable metastatic tumor Measurable or evaluable disease. (RECIST 1.1)
6. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment.
7. Patients with sufficient oral intake.
8. Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
i. Leukocyte >=3,000/mm3
Neutrophil >=1,500/mm3
ii. Platelets >=100,000/mm3
iii. Hemoglobin >=9.0g/dl
iv. Total bilirubin <= 1.5ml/dl
v. AST and ALT <= 100IU/l
(150IU/l in case of liver metastasis)
vi. Serum creatinine <= 1.3mg/dl
vii. INR < 1.5
viii. urinary protein <= 1+
7. survival more than 3 months.
8. Patients with written informed consent.

Key exclusion criteria

1. With a history of severe drug allergic response
2. Pregnant or lactating women or women of childbearing potential.
3. Uncontrolled infection.
4. With a history of severe systemic diseases.
5. Evidence of cardiovascular abnormalities.
6. Evidence of gastrointestinal bleeding
7. Evidence of sensory disturbance
8. Evidence of severe diarrhea
9. Evidence of ascites or pleural effusion needed to treat.
10. Evidence of gstrointestinal obstraction.
11. Evidence of peritoneal dissemination
12. Evidence of brain metastasis
13. History of hematemesis
14. History of cardiovascular events including unstable angina, cardiac infarction, cerebral infarction and pulmonary embolism
15. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks.
16. Evidence of bleeding diathesis or coagulopathy.
17. Administering antithrombotic drugs
18. blood transfusion within 2 weeks.
19. Multiple primary cancers within 5 years.
20. patients with administration of steroids.
21. Patients who have active hepatitis type B.
22. contraindication of S-1, L-OHP, BV administration
23. Other conditions not suitable for this study.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Dai Manaka

Organization

Kyoto-Katsura Hospital

Division name

Department of Surgery

Zip code

Address

17, Yamada-Hirao, Nishikyo, Kyoto-city, 615-8256, Kyoto, Japan

TEL

075-391-5811

Email

d_manaka@katsura.com

Name of contact person

1st name
Middle name
Last name	Dai Manaka

Organization

Kyoto-Katsura Hospital

Division name

Department of Surgery

Zip code

Address

17, Yamada-Hirao, Nishikyo, Kyoto-city, 615-8256, Kyoto, Japan

TEL

075-391-5811

Homepage URL

Email

noriko.fujita@katsura.com

Institute

Kyoto-Katsura Hospital

Institute

Department

Personal name

Organization

NONE

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

10

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2014

Year

08

Month

04

Day

Date of IRB

Anticipated trial start date

2014

Year

10

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

10

Month

16

Day

Last modified on

2014

Year

10

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017748