UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000883
Receipt number R000001066
Scientific Title Phase I Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan(FOLFOXIRI) for Metastatic or Reccurence Colorectal Cancer
Date of disclosure of the study information 2007/11/08
Last modified on 2009/09/04 22:01:48

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Basic information

Public title

Phase I Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan(FOLFOXIRI) for Metastatic or Reccurence Colorectal Cancer

Acronym

FOLFOXIRI(P-I)

Scientific Title

Phase I Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan(FOLFOXIRI) for Metastatic or Reccurence Colorectal Cancer

Scientific Title:Acronym

FOLFOXIRI(P-I)

Region

Japan


Condition

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Determining the maximum tolerable dose(MTD) and recomended dose(RD)

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety

Key secondary outcomes



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

5FU
Leucovorin
Irinotecan
Oxaliplatin

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Colorectal cancer histologically confirmed as adenocarcinoma
2. Unresectable metastatic or recurrence colorectal cancer
3. Interval of at least 3 weeks between last chemotherapy treatment and start of present chemotherapy regimen
4.
5. Age from 20 to 70 years
6. ECOG performance status of 0, 1
7. Without history of other active malignancy
8. Interval of at least 4 weeks between last operation and start of present chemotherapy regimen
9.
a) leukocyte count of at least 3500/mm3
b) neutrophils count of at least 1500/mm3
c)
d) platelet count of at least 100000/mm3
e) AST, ALT 5 x normal values or less
f) serum bilirubin less than 1.2mg/dL
g) serum creatinine of 1.5mg/dL or less
10. Written informed consent

Key exclusion criteria

1. Severe infection
2.
3. History of Irinotecan, and Oxaliplatin use
4. Severe complication
5.
6. Regular use of
7. History of thromboembolism
8. Unmanageable hyper tention
9. Active ulcer
10. Symptomatic brain metastasis
11.
12.
13.
14. History of radiotherapy
15. Massive pleural effusion required drainage
16. Persistent diarrhea
17.
18.
19. HBs antigen and HCV antigen positive
20. Pregnancy or the desire to preserve fecundity
21.
22. Psychological disease deemed to unacceptable for inclusion to the study
23.
24. Inadequate physical condition, as diagnosed by primary physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasutsuna Sasaki

Organization

Conprehensive Cancer Center, Saitama Medical University International Medical Center

Division name

Department of Clinical Oncology

Zip code


Address

1397-1 Yamane Hidaka Saitama

TEL

042-984-4111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yu Sunakawa

Organization

Conprehensive Cancer Center, Saitama Medical University International Medical Center

Division name

Department of Clinical Oncology

Zip code


Address


TEL


Homepage URL


Email

yu_s@saitama-med.ac.jp


Sponsor or person

Institute

Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center

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

2007 Year 11 Month 08 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

Completed

Date of protocol fixation

2007 Year 09 Month 05 Day

Date of IRB


Anticipated trial start date

2007 Year 09 Month 01 Day

Last follow-up date

2009 Year 09 Month 01 Day

Date of closure to data entry

2009 Year 09 Month 01 Day

Date trial data considered complete

2009 Year 10 Month 01 Day

Date analysis concluded

2009 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 11 Month 08 Day

Last modified on

2009 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001066


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name