UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009014
Receipt number R000010578
Scientific Title Phase II study of TS-1 / oxaliplatin(G-SOX) plus bevacizumab treatment for elderly advanced colorectal cancer patients.(GIANTS study)
Date of disclosure of the study information 2012/11/01
Last modified on 2012/12/20 16:11:12

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Basic information

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

Condition

colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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


Assessment

Primary outcomes

progression-free survival(PFS)

Key secondary outcomes

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


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

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



Eligibility

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


Research contact person

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



Public contact

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



Sponsor or person

Institute

University of Miyazaki Hospital.

Institute

Department

Personal name



Funding Source

Organization

University of Miyazaki Hospital.

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

2012 Year 11 Month 01 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name