UMIN-ICDS Clinical Trial

Public title

A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer

Acronym

TFTD plus Bmab for unresectable colorectal cancer

Scientific Title

A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer

Scientific Title:Acronym

TFTD plus Bmab for unresectable colorectal cancer

Region

Japan

Condition

unresectable advanced colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate time to treatment failure of TFTD plus Bevacizumab therapy for unresectable advanced colorectal cancer

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Time to treatment failure

Key secondary outcomes

Safety and efficacy

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

TFTD: fixed dose
Bevacizumab: fixed dose

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

Patients who satisfy all the following criteria are enrolled.
1. Unresectable or recurrent colorectal cancer patients confirmed histopathologically as colorectal cancer.
2. It does not have treatment history by TFTD (Lonsurf) and meets one of the following criteria.
5-FU, L-OHP, CPT-11 already treated
5-FU, L-OHP, CPT-11 unacceptable
Cases who cannot performed for strong treatment.
3. Lesions can be confirmed by image examination within 28 days before registration (measurable lesions are not essential)
4. Performance status (ECOG): 0 to 2 cases.
5. Age >=20
6. A case expected more than 3 months from the administration start date.
7. Case where clinical laboratory test values satisfy all of the following conditions (latest inspection value within 14 days before registration)
[Hematology test value]
White blood cell count >= 3,000 / mm 3, and <= 12,000 mm 3
Number of neutrophils >= 1,500 / mm 3
Number of platelets >= 100,000 / mm 3
Hemoglobin >= 8.0 g / dl
[Liver function test value]
AST (GOT), ALT (GPT) <= 100 U / l (200 U / l in cases of liver metastasis) or less
[Renal function test value]
Serum creatinine <= 1.50 mg / dL
8. Patients with test urine or normal urinalysis with proteinuria less than 1+ (24 hours of urine storage when test urine or 2 >= 2 + proteinuria in normal urinalysis, urine protein 1000 mg can participate if it is less than)
9. Patients without blood transfusion within 14 days before registration
10. Patients who has written informed consent.

Key exclusion criteria

Patients who conflict with one of the following will not be included in this clinical study.
1. Patients with simultaneous active malignant disease.
2. Patients who had history of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic disorder (thrombosis of the venous port or catheter or superficial venous thrombosis is not considered serious).
3. Patients with serious bleeding disorder, vasculitis, or serious gastrointestinal bleeding within 3 months before acquiring consent.
4. Patients with gastrointestinal perforation and / or history of fistula.
5. Patients with a history of pulmonary hemorrhage (hemoptysis).
6. Despite standard medical management, patients with uncontrollable arterial hypertension.
7. Patients with serious or unrecovered wounds, a history of peptic ulcer or fracture.
8. Patients with bowel obstruction, complication of inflammatory bowel disease or extensive intestinal resection, patients with Crohn's disease, ulcerative colon or chronic diarrhea.
9. Patients with serious drug allergy.
10. Patients with infection with fever over 38.0.
11. Patients with double active cancers which mean synchronous double cancers or metachronous double cancers with a disease-free period within 5 years.
12. Patients with brain metastasis.
13. Patients with severe complications such as the following.
Patients with complications of infection during antibiotic administration.
Patients with complications of treatment or poor control due to continued use of insulin.
Patients of complication of hypertension with poor control.
Patients with myocardial infarction that developed within 6 months.
Patients with unstable angina.
Patients in which liver cirrhosis was complicated.
Patients in which interstitial pneumonia and pulmonary fibrosis are complicated.
14. Pregnant or nursing female.
15. Patient with mental illness.
16. Not appropriate for the study at the physician's assessment.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Hiroaki Nagano

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterological, Breast and Endocrine Surgery

Zip code

Address

1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Email

hnagano@yamaguchi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Nobuaki Suzuki

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterological, Breast and Endocrine Surgery

Zip code

Address

1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Homepage URL

Email

nobusuzu@yamaguchi-u.ac.jp

Institute

Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

2019

Year

01

Month

23

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

Open public recruiting

Date of protocol fixation

2018

Year

12

Month

12

Day

Date of IRB

Anticipated trial start date

2018

Year

12

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

01

Month

23

Day

Last modified on

2019

Year

01

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040531