UMIN-CTR Clinical Trial

Public title

Phase II study of TS-1 / oxaliplatin(G-SOX) plus bevacizumab treatment for elderly advanced colorectal cancer patients.(GIANTS study)

Acronym

GIANTS study

Scientific Title

Phase II study of TS-1 / oxaliplatin(G-SOX) plus bevacizumab treatment for elderly advanced colorectal cancer patients.(GIANTS study)

Scientific Title:Acronym

GIANTS study

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluate the efficacy and safety of TS-1 / oxaliplatin(G-SOX) plus bevacizumab treatment for elderly advanced colorectal cancer patients.
Primary endpoint is to evaluate the progression-free survival.
Secondary endpoint is to evaluate the overall survival, response rate, and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

progression-free survival(PFS)

Key secondary outcomes

overall survival(OS), response rate(RR), and safety.

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

TS-1 administered for 14 days followed by 7 days rest according to body surface area.
L-OHP is administered intravenously in 100 mg/m2 at day 1.
Bevacizumab is administered intravenously in 7.5 mg/kg at day 1

Cycles are repeated every 3 weeks

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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Untreated recurrent or advanced colorectal cancer
2. Age 70=<
3. ECOG performance status of 0 to 2
4. The presence of evaluable disease based on the recist criterion. (within 30 days before registration)
5. No prior chemotherapy
6. Sufficient oral intake
7. Sufficient function of important organs
Leu: >=4,000 /mm3, <=12,000 /mm3
Neu: >= 1,500 /mm3
Plt: >= 100,000 /mm3
Hemoglobin: >= 9.0 g/dL
Total.bil: =< 2.0 mg/dL
ALT<=100IU/L(ALT<=200IU/L with liver metastases)
AST<=100IU/L(AST<=200IU/L with liver metastases)
creatinine<=1.5mg/dL
Ccr or eGFR: >= 50 ml/min
proteinuria: =<2+
INR: =<1.5
8. Expected more than 3 months survival
9. With written informed consent

Key exclusion criteria

1. History of the severe hypersensitivity
2. Active infection and inflammation
3. Patients have gastrointestinal perforation or bleeding
4. High grade peritoneal metastasis
5. Severe complications
6. Symptomatic or asymptomatic but treated heart disease
7. Patients have hemoptysis
8. Patients have peripheral sensory neuropathy
9. Watery stools or diarrhea
10. Massive pleural or abdominal effusion
11. Metastasis to CNS
12. History of the perforation of the digestive tract within 6 months before registration
13. History of the thromboembolism, brain infarction, lung infarction, brain infarction or pneumonitis
14. operation within 28 days
15. artificial anus within 14 days
16. congenital bleeding predisponency or abnormality of hemostasis
17. Patients have anticoagulant agent
18. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
19. Patients under treatment with flucytosine
20. With contraindicate TS-1, L-OHP, Bevacizumab
21. Patients under treatment with steroid
22. High-grade stricture
23. Pregnant or lactating woman or no birth-control
24. Other patients who are unfit for the study as determined by the attending physician.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Haruhiko Inatsu

Organization

University of Miyazaki Hospital.

Division name

First Department of Internal Medicine, Faculty of Medicine

Zip code

Address

5200 Kihara, Kiyotake, Miyazaki

TEL

0985-85-1510

Email

Name of contact person

1st name
Middle name
Last name	Koji Nakashima

Organization

University of Miyazaki Hospital.

Division name

First Department of Internal Medicine, Faculty of Medicine

Zip code

Address

5200 Kihara, Kiyotake, Miyazaki

TEL

0985-85-1510

Homepage URL

Email

Institute

University of Miyazaki Hospital.

Institute

Department

Personal name

Organization

University of Miyazaki Hospital.

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

2012

Year

11

Month

01

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

2012

Year

09

Month

21

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

01

Day

Last modified on

2012

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010578