UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001340
Receipt number R000001628
Scientific Title Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer
Date of disclosure of the study information 2008/08/29
Last modified on 2017/01/13 13:38:07

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Basic information

Public title

Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer

Acronym

Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer(KSCC0701)

Scientific Title

Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer

Scientific Title:Acronym

Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer(KSCC0701)

Region

Japan


Condition

Condition

Unresectable advanced/recurrent colorectal cancer

Classification by specialty

Medicine in general Gastroenterology Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Safety and efficacy of Alternating mFOLFOX6 and FOLFIRI every 4cycles as First line Therapy in Advanced colorectal Cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

RR

Key secondary outcomes

Safety,
PFS, OS


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

Alternating mFOLFOX6 and FOLFIRI every 4cycles.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1.colorectal cancer, cytologically and/or histrogically
2.Unresectable advanced/recurrent colorectal cancer
3.no prior chemotherapy
4.no prior radiotherapy
5.age: 20-75 years old
6.Performance Status (ECOG): 0-2
7.with measurable lesions
8.Life expectancy estimated >= 3 months
9.Sufficient organ functions
10.witten informed consents

Key exclusion criteria

1. Administering antithrobotic drug within 7 days
2. Serious complications (renal failure or hepatic failure)
3. Serious drug hypersensitivity or a history of drug allergy
4. Peripheral neuropathy
5. Active concomitant malignancy
6. Active infections
7. High blood pressure and diabetic that cannot be controlled
8. symptomatic or asymptomatic but treated heart disease
9. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema
10. histry of mental disturbances or cerebrovascular attach
11. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer
12. Plerral effusion, peritoneal fluid and pericardial fluid
13. Symptomatic brain metastasis
14. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity
15. Need to treatment with atazanavir sulfate
16. under coutinuous steroid therapy
17. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
18. on other clinical trial
19. Other conditions not suitable for this study

Target sample size

47


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maehara Yoshihiko

Organization

Kyushu University

Division name

Dpt. of surgery and science

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582

TEL

092-631-2920

Email

kscc2@cres-kyushu.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name KSCC

Organization

CReS

Division name

KSCC

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582

TEL

092-631-2920

Homepage URL

http://www.ks-cc.jp/

Email

kscc2@cres-kyushu.or.jp


Sponsor or person

Institute

KSCC

Institute

Department

Personal name



Funding Source

Organization

CReS

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

九州大学(福岡県)
貝塚病院(福岡県)
国立病院機構九州医療センター(福岡県)
公立学校共済組合九州中央病院(福岡県)
済生会福岡総合病院(福岡県)
福岡歯科大学医科歯科総合病院(福岡県)
産業医科大学(福岡県)
新日鐵八幡記念病院(福岡県)
国立病院機構福岡東医療センター
社会保険田川病院(福岡県)
社会保険仲原病院(福岡県)
久留米大学(福岡県)
久留米大学医療センター(福岡県)
社会保険久留米第一病院(福岡県)
聖マリア病院(福岡県)
公立八女総合病院(福岡県)
大牟田市立総合病院(福岡県)
国立病院機構嬉野医療センター(佐賀県)
済生会唐津病院(佐賀県)
健康保険諫早総合病院(長崎県)
白十字会 佐世保中央病院(長崎県)
長崎大学(長崎県)
春回会 井上病院(長崎県)
光晴会病院(長崎県)
医理会 柿添病院(長崎県)
熊本赤十字病院(熊本県)
熊本大学(熊本県)
健康保険人吉総合病院(熊本県)
大分赤十字病院(大分県)
国立病院機構大分医療センター(大分県)  
国立病院機構別府医療センター(大分県)
大分大学(大分県)
中津市立中津市民病院(大分県)
小林市立病院(宮崎県)
宮崎県立延岡病院(宮崎県)
社会保険宮崎江南病院(宮崎県)
国立病院機構南九州病院(鹿児島県)
今給黎総合病院(鹿児島県)
潤愛会 鮫島病院(鹿児島県)
鹿児島大学(鹿児島県)
鹿児島厚生連病院(鹿児島県)
鹿児島共済会南風病院(鹿児島県)
済生会川内病院(鹿児島県)
出水郡医師会立阿久根市民病院(鹿児島県)
県民健康プラザ鹿屋医療センター(鹿児島県)
鹿児島県立薩南病院(鹿児島県)
中頭病院(沖縄県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
琉球大学(沖縄県)
北部地区医師会病院(沖縄県)
広島赤十字・原爆病院(広島県)
松山赤十字病院(愛媛県)


Other administrative information

Date of disclosure of the study information

2008 Year 08 Month 29 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2007 Year 06 Month 21 Day

Date of IRB


Anticipated trial start date

2007 Year 07 Month 01 Day

Last follow-up date

2009 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2012 Year 04 Month 13 Day


Other

Other related information



Management information

Registered date

2008 Year 08 Month 29 Day

Last modified on

2017 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001628


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name